AMS 700? CX TENACIO? PUMP
Received Jul 13, 2026 · Event occurred Jun 17, 2026
Report 2124215-2026-37518 · MDR key 25806668
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404434Catalog number
72404434
Lot number
1100784774
Product problems
- Material Puncture/Hole
- Migration
Patient
64 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100812152. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE DISTAL END OF THE LEFT CYLINDER OF AN INFLATABLE PENILE PROSTHESIS (IPP) HAD MIGRATED OUT OF THE CORPOROTOMY TO THE SCROTUM. UPON EXPLANTATION, IT WAS FOUND THAT THE OUTER SILICONE LAYER HAD RUPTURED. AS A RESULT, THE ENTIRE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.