FDA Adverse Event
Malfunction
Summary report: N
OPEN END URETERAL AXXCESS CATHETER
MDR report key: 18293001
·
Received December 8, 2023
Report
- Report Number
- 2124215-2023-69594
- Event Type
- Malfunction
- Date Received
- December 8, 2023
- Date of Event
- November 20, 2023
- Report Date
- December 8, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- GBM
- UDI-DI
- 08714729751557
- PMA / PMN Number
- K830840
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: IMDRF DEVICE CODE CODE A020504 CAPTURES THE REPORTABLE EVENT OF PACKAGE RIP.
Description of Event or Problem · 0
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPEN END URETERAL AXXCESS CATHETER WAS USED DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON NOVEMBER 20, 2023. DURING PREPARATION, UPON GETTING THE STERILE PRODUCT OUT OF ITS PEEL PACK, IT WAS NOTICED THAT IT WAS RIPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OPEN END URETERAL AXXCESS CATHETER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 222447 | OPEN END URETERAL AXXCESS CATHETER | CATHETER, URETHRAL | GBM | BOSTON SCIENTIFIC CORPORATION | M0064001160 | 0032528450 | 08714729751557 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |