AMS 700 CX MS PUMP
Received Jul 22, 2026 · Event occurred Jun 16, 2026
Report 2124215-2026-39541 · MDR key 25905519
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404238Catalog number
72404238
Lot number
1100875585
Product problems
- Material Puncture/Hole
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720185-01 SERIAL NUMBER: N/A BATCH/LOT NUMBER: 1100926311 MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML UNIQUE IDENTIFIER (UDI) #: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE FOR THIS INFLATABLE PENILE PROSTHESIS (IPP), THE PHYSICIAN REPORTEDLY PUNCTURED A CYLINDER WITH A SUTURE NEEDLE WHILE CLOSING THE INCISION, RESULTING IN A HOLE IN THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED WITH A NEW PROSTHESIS. THERE WERE NO PATIENT COMPLICATIONS.