FDA Adverse Event
Malfunction
Summary report: N
COYOTE
MDR report key: 20915846
·
Received December 12, 2024
Report
- Report Number
- 2124215-2024-77293
- Event Type
- Malfunction
- Date Received
- December 12, 2024
- Date of Event
- November 25, 2024
- Report Date
- December 12, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DQY
- UDI-DI
- 08714729797098
- PMA / PMN Number
- K111295
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
D2B PRO CODE (PRODUCT CODE): DQY, LIT.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE BALLOON BECAME STUCK WITH THE WIRE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED POPLITEAL ARTERY. A 4.0MM X 150MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR ENDOVASCULAR THERAPY PROCEDURE. DURING THE PROCEDURE, THE BALLOON WAS INSERTED AND BECAME STUCK WITH THE JUPITER FC3 GUIDEWIRE. BOTH THE BALLOON AND THE WIRE WERE REMOVED OUT OF THE BODY AS ONE UNIT. THE PROCEDURE WAS CANCELED DUE TO THE CONDITION OF THE LESION, WHICH MADE IT DIFFICULT FOR THE WIRE AND BALLOON TO CROSS. THE PHYSICIAN DETERMINED THAT IT WAS DIFFICULT TO CONTINUE WITH THE PROCEDURE EVEN IF THE DEVICE IS REPLACED. NO COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2142059 | COYOTE | CATHETER, PERCUTANEOUS | DQY | BOSTON SCIENTIFIC CORPORATION | H74939185401510 | 0032026670 | 08714729797098 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | GUIDEWIRE: JUPITER FC3 |