AMS 700 CXR
Received Jul 15, 2026 · Event occurred Jun 10, 2026
Report 2124215-2026-38141 · MDR key 25833739
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404013Catalog number
72404013
Lot number
1000419634
Product problems
- Mechanical Problem
- Material Puncture/Hole
Patient
65 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 72404310 SERIAL NUMBER: N/A BATCH/LOT NUMBER: 1000586350 MODEL/CATALOG DESCRIPTION: PUMP MS UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: 72404161 SERIAL NUMBER: N/A BATCH/LOT NUMBER: 1000443829 MODEL/CATALOG DESCRIPTION: RESERVOIR 65ML PC UNIQUE IDENTIFIER (UDI) #: (B(4).
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 A CRACK WAS FOUND IN THE CYLINDER CONNECTING TUBE. ALL COMPONENTS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.