PERCUFLEX
Report
- Report Number
- 2124215-2025-86778
- Event Type
- Malfunction
- Date Received
- November 26, 2025
- Date of Event
- October 28, 2025
- Report Date
- March 3, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FAD
- UDI-DI
- 08714729040279
- PMA / PMN Number
- K834468
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK H6: DEVICE CODE A0406 CAPTURES THE REPORTABLE EVENT OF STENT MATERIAL DEFORMATION INSIDE THE PATIENT. DEVICE CODE A040609 CAPTURES THE REPORTABLE EVENT OF KINKED INSIDE THE PATIENT.
DEVICE CODE A0406 CAPTURES THE REPORTABLE EVENT OF STENT MATERIAL DEFORMATION INSIDE THE PATIENT. DEVICE CODE A040609 CAPTURES THE REPORTABLE EVENT OF KINKED INSIDE THE PATIENT. INVESTIGATION ANALYSIS: UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS PERCUFLEX URETERAL STENT UNDERWENT A THOROUGH ANALYSIS. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED THAT THE RENAL COIL WAS KINKED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. BASED ON THE INFORMATION AVAILABLE AND ANALYSIS RESULTS, IT IS POSSIBLE TO CONCLUDE THAT THIS ISSUE COULD BE CAUSED BY OPERATIONAL FACTORS, PROBABLY DUE TO SOME MANIPULATION DURING THE PROCEDURE THAT COULD HAVE CAUSED THE KINKS. A CONCLUSION CODE OF ADVERSE EVENT RELATED TO PROCEDURE WAS ASSIGNED TO THIS INVESTIGATION.
IT WAS REPORTED THAT A PERCUFLEX URETERAL STENT WAS USED DURING A LITHOTRIPSY PROCEDURE. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT WAS FOLDED AND TWISTED AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
IT WAS REPORTED THAT A PERCUFLEX URETERAL STENT WAS USED DURING A LITHOTRIPSY PROCEDURE. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT WAS FOLDED AND TWISTED AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2673134 | PERCUFLEX | CATHETER, BILIARY, DIAGNOSTIC | FAD | BOSTON SCIENTIFIC CORPORATION | M0061453520 | 0034386010 | 08714729040279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male |