FDA Adverse Event
Malfunction
Summary report: N
COYOTE ES
MDR report key: 11585257
·
Received March 29, 2021
Report
- Report Number
- 2134265-2021-04042
- Event Type
- Malfunction
- Date Received
- March 29, 2021
- Date of Event
- March 22, 2021
- Report Date
- March 29, 2021
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LIT
- UDI-DI
- 08714729767176
- PMA / PMN Number
- K093636
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL BELOW THE KNEE. A 2MM X 20MM X 143CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES FOR 14 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS GOOD POST PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 482151 | COYOTE ES | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | BOSTON SCIENTIFIC CORPORATION | 24691 | 0025295859 | 08714729767176 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |