AMS 700 CXR MS PUMP
Received Jun 30, 2026 · Event occurred Jun 2, 2026
Report 2124215-2026-34940 · MDR key 25673519
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404267Catalog number
72404267
Lot number
1100526415
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
77 YR · Male
- Erosion
Narrative
Additional Manufacturer Narrative
THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION. THE REPORTED PATIENT SYMPTOM(S) ARE KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE. BASED ON THE INFORMATION AVAILABLE, THE CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION. MODEL NUMBER/CATALOG NUMBER: 72404155. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100696369. MODEL/CATALOG DESCRIPTION: RESERVOIR 65 ML PC/IZ. UNIQUE IDENTIFIER (UDI) #: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED EROSION IN THE RIGHT CYLINDER THROUGH THE GLANDS, WITH SOME CENTIMETERS OF THE CYLINDER VISIBLE EXTERNALLY. AS A RESULT, THE RIGHT CYLINDER WAS EXPLANTED, AND THE TUBING WAS DEACTIVATED TO ALLOW THE LEFT CYLINDER TO CONTINUE FUNCTIONING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.