FDA Adverse Event
Malfunction
Summary report: N
PERCUFLEX PLUS
MDR report key: 22248475
·
Received June 17, 2025
Report
- Report Number
- 2124215-2025-39285
- Event Type
- Malfunction
- Date Received
- June 17, 2025
- Date of Event
- May 22, 2025
- Report Date
- June 17, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FAD
- UDI-DI
- 08714729056812
- PMA / PMN Number
- K924608
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: DEVICE CODE A040601 CAPTURES THE REPORTABLE EVENT OF STENT BUCKLED MATERIAL.
Description of Event or Problem · 0
IT WAS REPORTED THAT A PERCUFLEX PLUS URETERAL STENT WAS USED DURING A STONE PROCEDURE. DURING INSERTION AND INSIDE THE PATIENT, THE DEVICE COULD NOT BE ADVANCED. IT WAS NOTED THAT THE SURFACE OF THE STENT HAD WRINKLES. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1691626 | PERCUFLEX PLUS | CATHETER, BILIARY, DIAGNOSTIC | FAD | BOSTON SCIENTIFIC CORPORATION | M0061752530 | 0034218351 | 08714729056812 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male |