FDA Adverse Event
Malfunction
Summary report: N
SOFT-VU ANGIOGRAPHIC CATHETER
MDR report key: 2000039
·
Received February 18, 2011
Report
- Report Number
- 1319211-2011-00018
- Event Type
- Malfunction
- Date Received
- February 18, 2011
- Date of Event
- January 20, 2011
- Report Date
- February 16, 2011
- Manufacturer
- ANGIODYNAMICS
- Product Code
- DQO
- PMA / PMN Number
- K9141999
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALTHOUGH IT WAS INDICATED BY THE END USER THAT THE REPORTED DEFECTIVE DEVICE WAS AVAILABLE, IT HAS YET TO BE RETURNED TO THE MFR. AN INVESTIGATION INTO THE ROOT CAUSE FOR THE INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A F/U MEDWATCH IS AVAILABLE FOR EVAL.
Description of Event or Problem · 1
AS REPORTED BY THE END USER IN (B)(6), WHILE PERFORMING A DIAGNOSTIC ANGIOGRAM, THE TIP OF THE ANGIOGRAPHIC CATHETER BROKE OFF. AN ATTEMPT TO RETRIEVE THE TIP WITH A GOOSENECK SNARE WAS UNSUCCESSFUL. AN ARTERIOTOMY WAS REQUIRED TO SUCCESSFULLY RETRIEVE THE TIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOFT-VU ANGIOGRAPHIC CATHETER | SOFT-VU ANGIOGRAPHIC CATHETER | DQO | ANGIODYNAMICS | NA | 975635 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |