FDA Adverse Event
Malfunction
Summary report: N
ANGIOJET AVX
MDR report key: 13108963
·
Received December 29, 2021
Report
- Report Number
- 2134265-2021-15910
- Event Type
- Malfunction
- Date Received
- December 29, 2021
- Date of Event
- December 10, 2021
- Report Date
- December 29, 2021
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DXE
- UDI-DI
- 08714729889045
- PMA / PMN Number
- K133629
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT LOSS OF ASPIRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. AN ANGIOJET AVX CATHETER WAS ADVANCED FOR THROMBECTOMY PROCEDURE. HOWEVER, UPON REMOVING THE THROMBUS, THE DEVICE LOST SUCTION AND THE PUMP OBSERVED LEAKING. THE SHAFT WAS OBSERVED TO BE BROKEN ON A PART OF THE DEVICE EXTERNAL TO THE PATIENT. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2005457 | ANGIOJET AVX | CATHETER, EMBOLECTOMY | DXE | BOSTON SCIENTIFIC CORPORATION | 45026 | 0026103135 | 08714729889045 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |