FDA Adverse Event
Malfunction
Summary report: N
COYOTE ES
MDR report key: 18806410
·
Received February 29, 2024
Report
- Report Number
- 2124215-2024-11472
- Event Type
- Malfunction
- Date Received
- February 29, 2024
- Date of Event
- February 8, 2024
- Report Date
- February 29, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LIT
- UDI-DI
- 08714729767336
- PMA / PMN Number
- K093636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED BELOW THE KNEE WITH A STENOSIS OF 100% THAT WAS MODERATELY TORTUOUS AND SEVERELY CALCIFIED. A 2MM X 20MM X 142CM COYOTE ES WAS ADVANCED FOR DILATION. DURING PROCEDURE, THE BALLOON RUPTURED ON THE FIRST INFLATION AT 6 ATMOSPHERES FOR 1 SECOND. THE DEVICE WAS REPLACED FOR ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. NO COMPLICATIONS WERE REPORTED, AND PATIENT STATUS WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 927427 | COYOTE ES | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | BOSTON SCIENTIFIC CORPORATION | 24701 | 0031068071 | 08714729767336 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |