AMS 700 CXR MS PUMP
Received Jul 20, 2026 · Event occurred Dec 1, 2025
Report 2124215-2026-38805 · MDR key 25876904
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404262Catalog number
72404262
Lot number
0175677009
Product problems
- Fluid/Blood Leak
- Mechanical Problem
- Material Puncture/Hole
Patient
76 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT'S INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FUNCTIONING PROPERLY. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH IT WAS IDENTIFIED THAT THE TUBING HAD FRACTURED ABOVE THE PUMP CAUSING FLUID LOSS. THE CYLINDERS AND PUMP WERE REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 72404155. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 0179195008. MODEL/CATALOG DESCRIPTION: RESERVOIR 65 ML PC/IZ. UNIQUE IDENTIFIER (UDI) #: (B)(4).