InjuryJCW
AMS 700 CX MS Pump
Received Jul 27, 2026 · Event occurred Jun 29, 2026
Report 2124215-2026-40043 · MDR key 50037256
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404238Catalog number
72404238
Lot number
1100875600
Product problems
- Degraded
- Material Puncture/Hole
- Inadequacy of Device Shape and/or Size
Patient
Not reported
- Urinary Retention
Narrative
Description of Event or Problem
It was reported that the patient with this Inflatable Penile Prosthesis (IPP) experienced urinary retention and required catheterization for several weeks. At the three week postoperative follow up visit, the physician noted buckling and breaks of the cylinders. Upon inspection, oversizing of the cylinders was suspected to have contributed to the buckling. As a result, the cylinders and pump were explanted and replaced. No further patient complications were reported.