FDA Adverse Event
Malfunction
Summary report: N
COYOTE ES
MDR report key: 18032168
·
Received October 30, 2023
Report
- Report Number
- 2124215-2023-60179
- Event Type
- Malfunction
- Date Received
- October 30, 2023
- Date of Event
- October 2, 2023
- Report Date
- October 30, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LIT
- UDI-DI
- 08714729767190
- 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 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 2MM X 40MM X 145CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR 5 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1851703 | COYOTE ES | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | BOSTON SCIENTIFIC CORPORATION | 24691 | 0031797137 | 08714729767190 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |