AMS 800 ARTIFICIAL URINARY SPHINCTER
Report
- Report Number
- 2124215-2025-88471
- Event Type
- Injury
- Date Received
- December 11, 2025
- Date of Event
- November 18, 2025
- Report Date
- January 27, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- EZY
- UDI-DI
- 00878953000626
- PMA / PMN Number
- P000053
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) NUMBER AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) NUMBER AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. EROSION AND URINARY INCONTINENCE ARE ACKNOWLEDGED WITHIN THE DFU AND ARE NOT RELATED TO OFF-LABEL USE OR FAILURE TO FOLLOW INSTRUCTIONS. THE REPORTED PATIENT SYMPTOMS OF EROSION AND URINARY INCONTINENCE ARE KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE.
IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT INCONTINENCE AND UNDERWENT AN ATTEMPTED URETHRAL CATHETER INSERTION. THE PATIENT HAD THE DEVICE IN PLACE, BUT THE CATHETER COULD NOT BE INSERTED. THE URETHRA WAS THEN EXAMINED WITH A CAMERA, WHICH REVEALED THE CUFF AND EVIDENCE OF EROSION. THE PHYSICIAN BELIEVES THE DEVICE WAS PROPERLY DEACTIVATED BEFORE THE CATHETER INSERTION ATTEMPT. THE PHYSICIAN STATED THAT THE DEVICE WILL BE REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.
IT WAS REPORTED THAT THE PATIENT WITH THIS ARTIFICIAL URINARY SPHINCTER (AUS) EXPERIENCED RECURRENT INCONTINENCE AND UNDERWENT AN ATTEMPTED URETHRAL CATHETER INSERTION. THE PATIENT HAD THE DEVICE IN PLACE, BUT THE CATHETER COULD NOT BE INSERTED. THE URETHRA WAS THEN EXAMINED WITH A CAMERA, WHICH REVEALED THE CUFF AND EVIDENCE OF EROSION. THE PHYSICIAN BELIEVES THE DEVICE WAS PROPERLY DEACTIVATED BEFORE THE CATHETER INSERTION ATTEMPT. THE PHYSICIAN STATED THAT THE DEVICE WILL BE REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2413724 | AMS 800 ARTIFICIAL URINARY SPHINCTER | DEVICE INCONTINENCE MECHANICAL/HYDRAULIC | EZY | BOSTON SCIENTIFIC CORPORATION | 72400024 | 00878953000626 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |