FDA Adverse Event
Malfunction
Summary report: N
AMPLATZ
MDR report key: 1941420
·
Received December 22, 2010
Report
- Report Number
- 1941420
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- December 1, 2010
- Report Date
- December 22, 2010
- Manufacturer
- EV3 INC.
- Product Code
- DXE
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VT, US
Narratives
Description of Event or Problem · 1
DURING ATTEMPTED RETRIEVAL OF A TEMPORARY VENA CAVA FILTER WITH A GOOSENECK SNARE THE RADIOPAQUE MARKER BAND BEGAN TO MIGRATE DOWN THE CATHETER. THE INTERVENTIONAL RADIOLOGIST WAS ABLE TO EXTRACT THE CATHETER WITH THE BAND STILL ON THE SNARE LOOP.====================== HEALTH PROFESSIONAL'S IMPRESSION======================FAILURE OF THE MARKER ATTACHMENT MECHANISM CREATED THE POTENTIAL FOR LEAVING THE MARKER WITHIN THE PATIENT.====================== MANUFACTURER RESPONSE FOR GOOSE NECK SNARE CATHETER, AMPLATZ======================THE MANUFACTURER HASN'T YET HAD AN OPPORTUNITY TO ASSESS THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMPLATZ | CATHETER, EMBOLECTOMY | DXE | EV3 INC. | * | 9358699 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |