FDA Adverse Event
Malfunction
Summary report: N
CONTOUR
MDR report key: 20789090
·
Received November 26, 2024
Report
- Report Number
- 2124215-2024-74642
- Event Type
- Malfunction
- Date Received
- November 26, 2024
- Date of Event
- October 31, 2024
- Report Date
- November 26, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- FAD
- UDI-DI
- 08714729058533
- PMA / PMN Number
- K974541
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: IMDRF DEVICE CODE A040601 CAPTURES THE REPORTABLE EVENT OF STENT BUCKLED INSIDE THE PATIENT.
Description of Event or Problem · 0
IT WAS REPORTED THAT, DURING THE URETEROSCOPY PROCEDURE A CONTOUR URETERAL STENT WAS USED, THE STENT BECAME ACCORDIONED OVER THE WIRE MAKING IT DIFFICULT TO PLACE; HOWEVER, THE STENT WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 862814 | CONTOUR | STENT, URETERAL | FAD | BOSTON SCIENTIFIC CORPORATION | M0061802230 | 0034432355 | 08714729058533 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |