FDA Adverse Event
Malfunction
Summary report: N
COYOTE ES
MDR report key: 9624939
·
Received January 23, 2020
Report
- Report Number
- 2134265-2020-00451
- Event Type
- Malfunction
- Date Received
- January 23, 2020
- Date of Event
- January 8, 2020
- Report Date
- January 23, 2020
- 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
Narratives
Additional Manufacturer Narrative · 1
(B)(6).
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 SEVERELY CALCIFIED VESSEL BELOW THE KNEEL. A 2MM X 40MM X 145CM COYOTE ES BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 2 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT PROBLEM AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 84207 | COYOTE ES | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | LIT | BOSTON SCIENTIFIC CORPORATION | 24691 | 0022926057 | 08714729767190 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |