FDA Adverse Event
Malfunction
Summary report: N
COYOTE ES
MDR report key: 18213240
·
Received November 27, 2023
Report
- Report Number
- 2124215-2023-66978
- Event Type
- Malfunction
- Date Received
- November 27, 2023
- Date of Event
- November 23, 2023
- Report Date
- November 27, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LIT
- UDI-DI
- 08714729767329
- 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 PATIENT UNDERWENT ENDOVASCULAR THERAPY FOR THE SEVERELY CALCIFIED ANTERIOR TIBIAL ARTERY CHRONIC TOTAL OCCLUSION. A JUPITER SFC GUIDEWIRE WAS ADVANCED INTO THE LESION; HOWEVER, THE WIRING TOOK A LONG TIME AND THE TIP OF THE GUIDEWIRE GOT WEAKENED. AFTER REPLACING THE GUIDEWIRE WITH ANOTHER JUPITER SFC, A 1.5MM X 20MM X 142CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A 2MM BALLOON CATHETER. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 536438 | COYOTE ES | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | BOSTON SCIENTIFIC CORPORATION | 24701 | 0031055766 | 08714729767329 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |