PERCUFLEX PLUS
Report
- Report Number
- 2124215-2025-59610
- Event Type
- Malfunction
- Date Received
- August 29, 2025
- Date of Event
- August 4, 2025
- Report Date
- October 6, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FAD
- PMA / PMN Number
- K924608
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK H6: DEVICE CODE A040501 CAPTURES THE REPORTABLE EVENT OF STENT CALCIFIED. BLOCKS B5, B6, AND B7, HAVE BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION PROVIDED ON SEPTEMBER 15, 2025.
BLOCK H6: DEVICE CODE A040501 CAPTURES THE REPORTABLE EVENT OF STENT CALCIFIED.
IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS IMPLANTED IN THE PATIENT. FOLLOWING THE PROCEDURE, ON (B)(6) 2025, A STENT REPLACEMENT PROCEDURE WAS PERFORMED, AND THE STENT WAS FOUND TO BE ENCRUSTED. THE ENCRUSTED STENT WAS REMOVED, AND A NEW STENT OF THE SAME MODEL WAS PLACED WHICH SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS IMPLANTED IN THE PATIENT. FOLLOWING THE PROCEDURE, A STENT REPLACEMENT PROCEDURE WAS PERFORMED WITHIN 2 MONTHS. THE STENT WAS FOUND TO BE ENCRUSTED AND WAS SUCCESSFULLY REMOVED. THERE WAS NO INFORMATION IF A NEW STENT WAS PLACED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2879224 | PERCUFLEX PLUS | CATHETER, BILIARY, DIAGNOSTIC | FAD | BOSTON SCIENTIFIC CORPORATION | M0061752530 | 0033225046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |