2025 September AMS700 FDA Submitted MAUDE Events

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MAUDE - Manufacturer and User Facility Device Experience
The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.

Attached 2025 September AMS700 FDA Submitted MAUDE Events

A limited sample of 61 mechanical events had both Event Date and Date of Manufacture.
Median duration until a mechanical event without adjusting for shelf life - 4 years
Lowest - 4 months
Highest - 10 years. Congrats! An individual from South Korea had a cylinder tear event only after 10 years.

Mechanical Events - 117 (60%)
Total - 196

Mechanical Events Summary
####Cylinder Issues
• Breach (puncture/tear/rupture/outer-sleeve hole/delamination)
o Symptoms: won’t inflate or won’t hold pressure; sudden loss of rigidity.
o Notes: includes single-side holes, both cylinders ruptured near tube junctions, outer lining rupture with blood inside, “water leak,” delaminated cylinders found intra-op, hole seen on imaging/inspection.
o Fix: cylinder exchange or full IPP replacement; occasional conversion to TACTRA.

• Aneurysm / inner-layer ballooning
o Symptoms: curvature/asymmetry; can’t cycle.
o Notes: visible mesh; blood under first layer; sometimes only inner cylinder failed with outer intact.
o Fix: replace cylinders (± pump) or convert to malleable; reservoir often retained.

• Length/rigidity mismatch
o Symptoms: not enough to fill space; low rigidity/“low strength.”
o Notes: measurement/volume issue rather than material failure.
o Fix: upsize cylinders or add saline (no component removal in some cases).

• Pre-implant test failure
o Symptoms: one cylinder wouldn’t deflate on the back table.
o Notes: caught intra-op; alternative cylinders used.
o Fix: implant alternate cylinders; keep rest of system if sound.


####Tubing Issues
• Break in pump tubing
o Symptoms: fluid loss; device nonfunctional.
o Notes: confirmed “break in pump tubing.”
o Fix: replace affected components or entire system.

• Micro-puncture in tubing
o Symptoms: fluid loss; partial/failed inflation.
o Notes: reservoir sometimes retained and an additional reservoir added.
o Fix: replace cylinders and pump; revise plumbing.

• Crack in pump connecting tube
o Symptoms: fluid loss; device not cycling/under-inflation.
o Notes: found on revision; sometimes prompted pump-only swap, sometimes pump+cylinders.
o Fix: replace pump (± other runs); re-route/secure tubing.

• Crack in reservoir connecting tube
o Symptoms: leak; reservoir empty.
o Notes: identified on inspection two weeks post-complaint.
o Fix: replace reservoir and often pump; reconnect system.

• Hole in reservoir tubing
o Symptoms: fluid loss; non-inflation.
o Notes: source localized to reservoir line.
o Fix: reservoir exchange; reconnect to new/retained components.

• Crack in cylinder connecting tube (left/right)
o Symptoms: under-inflation/nonfunction.
o Notes: explicitly cited left or right cylinder run.
o Fix: replace affected cylinders and usually pump; re-plumb.

• Tubing detached at pump base
o Symptoms: inflation problem; system failure.
o Notes: detachment point at pump base.
o Fix: remove/replace IPP; ensure secure strain-relief.

• Twisted and fractured reservoir tubing near pump block
o Symptoms: fluid loss; device not functioning.
o Notes: torsion-related damage.
o Fix: full system replacement; re-route to avoid twist.

• Tubing too short / mal-routing (kinked/tensioned)
o Symptoms: discomfort; deflates during intercourse; “air” sounds.
o Notes: length/tension driver; kinks seen intra-op in a multi-fault case.
o Fix: re-route, elongate, or replace affected runs/components.

• Tubing perforation at pump–reservoir junction
o Symptoms: system fluid loss; non-inflation.
o Notes: in one case, an unrelated cylinder aneurysm also observed at explant.
o Fix: device replacement; rebuild junction with sound routing.

• Generic “leak in tubing / source uncertain”
o Symptoms: can’t inflate; reservoir empty on imaging; slow deflation.
o Notes: leak proven but exact run not identified.
o Fix: full system replacement.


####Pump Issues
• Actuation failure (hard to press / can’t be pressed / flat & no recoil / won’t cycle)
o Symptoms: can’t inflate; pump stays flat or doesn’t rebound.
o Notes: multiple reports; one confirmed non-leaking pump failed activation test.
o Fix: pump exchange; full system swap if co-failures.

• Won’t deflate
o Symptoms: persistent inflation/can’t deflate.
o Notes: valve dysfunction.
o Fix: pump replacement.

• Auto-deflation
o Symptoms: device loses pressure spontaneously.
o Notes: valve/seal issue.
o Fix: pump replacement.

• Pump-internal leak/air ingestion
o Symptoms: fluid + air within pump; pump can’t move fluid.
o Notes: connection fault inside pump suspected despite no visible hole.
o Fix: full system replaced (pump lineage changed to Tenacio in one case).

• Usability/ergonomics
o Symptoms: difficult to operate; dissatisfaction; inadequate hand fit/length.
o Notes: training issues; one swap MS ↔ Tenacio for better operation.
o Fix: retrain and/or pump type exchange; occasionally swap cylinders concurrently.

• Persistent auto-inflation after prior pump swap
o Symptoms: ongoing auto-inflation post-revision.
o Notes: may implicate non-pump dynamics (e.g., reservoir), but pump already exchanged.
o Fix: further evaluation; likely broader system revision.


####Reservoir Issues
• Puncture (iatrogenic, unrelated surgery)
o Symptoms: fluid loss; device nonfunctional.
o Notes: direct reservoir injury during another procedure.
o Fix: device removed; often converted to malleable (TACTRA).

• Neck/port leak with air ingress
o Symptoms: air in system; poor inflation.
o Notes: leak near neck confirmed intra-op.
o Fix: device replacement (reservoir exchange).

• Reservoir empty on imaging / system leak
o Symptoms: nonfunction; can’t inflate.
o Notes: in some cases cylinders later found delaminated.
o Fix: full system replacement or conversion to malleable.

• Migration / hernia context
o Symptoms: scrotal migration or abdominal bulge; urinary symptoms in some cases (across dataset).
o Notes: one case also had cylinder tear and kinked tubing.
o Fix: reservoir reposition/exchange; sometimes whole system replaced.

• Change of reservoir type
o Symptoms: n/a (clinical choice).
o Notes: swap to water-spring reservoir.
o Fix: reservoir replacement only.

• Packaging contamination (pre-use)
o Symptoms: n/a (not implanted).
o Notes: foreign material seen on opening; packaging intact.
o Fix: discard and use alternate device.

• Wear at fold (analysis finding)
o Symptoms: none reported in vivo.
o Notes: wear noted without leak on returned part.
o Fix: informational; no patient action tied to this finding.

• Midline relocation for hernia planning
o Symptoms: n/a.
o Notes: prophylactic move to avoid tubing interference.
o Fix: reservoir replacement/reposition only.

Biological Events Summary

####Erosion / Extrusion
• Pump erosion through scrotum (± infection) → exposure/pain → explant, often convert to TACTRA.
• Distal cylinder erosion → discomfort/exposure → cylinders or full system replaced.
• Cylinder herniation/outer-layer failure with painful bulge → explant.


####Malposition / Migration / Hernia
• Reservoir intravesical (in bladder) → persistent rigidity/can’t deflate → explant, often TACTRA.
• Reservoir migration or herniation (to scrotum/near bladder) → pain, urinary symptoms, palpable bulge → reposition or exchange; sometimes midline relocation.
• Palpable reservoir with inguinal hernia → abdominal bulge → reservoir replaced.
• Pump malposition/adhesion (riding high, protruding, adhered to testicle, hard-to-reach) → discomfort/operation difficulty → reposition or exchange; correct tubing length.
• Cylinder malposition (distal crossover or distal tip mid-corpora) → pain/cycling problem/under-inflation → revision or exchange; upsize if undersized.
• SST deformity from undersized cylinders despite glanulopexy → cylinders revised; reservoir retained.


####Infection / Inflammation
• Device or scrotal infection (pain, swelling, redness, purulence) → washout/explant; staged reimplant or convert to TACTRA.
• Hematoma → subsequent scrotal infection after revision → staged removals; later new IPP.
• Infection with pump exposure/erosion → explant (often TACTRA).
• Infection reported as unrelated to device → explant/replace (TACTRA).
• Infection not controlled after debridement/observation → full explant.
• Noninfectious inflammation (no organism noted) → component or full explant.


####Other (pain, wounds, tissue, usability, dissatisfaction)
• Pain/tenderness without infection (scrotal/abdominal) interfering with use → revision or replacement as needed.
• Pump usability/position complaints (training too brief, hard to find/press bulb, unsure deflate click) → retraining or pump type change/reposition.
• Tissue necrosis from pump base pressure (skin intact) → pump exchanged; antibiotics.
• Wound complications (dehiscence, open scrotal wound, recurrent ulcers) → local care and/or explant; later reimplant or malleable.
• Tissue thinning (MRI-identified base thinning or thin glans at risk of puncture) → revision/exchange.
• Recurrent incontinence associated with reported mechanical leak → device exchanged.
• Dissatisfaction/cosmesis (visible scarring, shape concerns) → device replaced.

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