AMS 700 CX MS Pump
Received Jun 26, 2026 · Event occurred May 28, 2026
Report 2124215-2026-34261 · MDR key 25638451
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404233-12Catalog number
72404233-12
Lot number
1100736332
Product problems
- Break
- Fluid/Blood Leak
- Inflation Problem
Patient
68 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH INABILITY TO INFLATE THE DEVICE. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED FLUID LOSS AND IDENTIFIED THAT THE ORIGINAL IMPLANT HAD A SUTURE STRIKE IN THE RIGHT CYLINDER. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 72404156, SERIAL NUMBER: N/A, BATCH/LOT NUMBER: 1100715384, MODEL/CATALOG DESCRIPTION: RESERVOIR 100 ML PC/IZ, UNIQUE IDENTIFIER (UDI) #: (B)(4).