FDA Adverse Event
Malfunction
Summary report: N
ANGIOJET AVX
MDR report key: 14167538
·
Received April 21, 2022
Report
- Report Number
- 2134265-2022-04417
- Event Type
- Malfunction
- Date Received
- April 21, 2022
- Date of Event
- March 29, 2022
- Report Date
- April 21, 2022
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DXE
- UDI-DI
- 08714729889045
- PMA / PMN Number
- K133629
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT SHAFT HOLE OCCURRED. AN ANGIOJET AVX WAS USED IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE UNKNOWN GUIDEWIRE COULD NOT GO STRAIGHT THROUGH THE WIRE LUMEN HOLE AND CAME OUT FROM ONE OF THE SIDE HOLES OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2418307 | ANGIOJET AVX | CATHETER, EMBOLECTOMY | DXE | BOSTON SCIENTIFIC CORPORATION | 45026 | 0028548092 | 08714729889045 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |