FDA Adverse Event
Malfunction
Summary report: N
COYOTE ES
MDR report key: 15568396
·
Received October 7, 2022
Report
- Report Number
- 2124215-2022-36645
- Event Type
- Malfunction
- Date Received
- October 7, 2022
- Date of Event
- September 13, 2022
- Report Date
- October 7, 2022
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LIT
- UDI-DI
- 08714729767350
- PMA / PMN Number
- K093636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT BALLOON TEAR OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED POSTERIOR TIBIAL VESSEL. A 2MM X 40MM X 144CM COYOTE ES BALLOON CATHETER WAS LOADED ON TO WIRE AND ADVANCED, HOWEVER, WHILE ADVANCING IT BEGAN TO TEAR FROM THE DISEASE IN THE VESSEL. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2897008 | COYOTE ES | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | BOSTON SCIENTIFIC CORPORATION | 24701 | 0029575783 | 08714729767350 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |