FDA Adverse Event
Malfunction
Summary report: N
COYOTE?
MDR report key: 25112257
·
Received May 7, 2026
Report
- Report Number
- 2124215-2026-24750
- Event Type
- Malfunction
- Date Received
- May 7, 2026
- Date of Event
- April 7, 2026
- Report Date
- May 7, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LIT
- UDI-DI
- 08714729796817
- 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
G4: PREMARKET / 510(K): K111295, K162350.
Description of Event or Problem · 0
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL NEAR THE ARTERIOVENOUS FISTULA ANASTOMOSIS. A 2.0MM X 220MM X 150CM COYOTE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INITIAL INFLATION AT 10 ATMOSPHERES FOR A FEW SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 328874 | COYOTE? | CATHETER, PERCUTANEOUS | LIT | BOSTON SCIENTIFIC CORPORATION | H74939185202210 | 0031396171 | 08714729796817 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |