FDA Adverse Event
Malfunction
Summary report: N
EXPRO ELITE SNARE
MDR report key: 2708541
·
Received August 6, 2012
Report
- Report Number
- 1225894-2012-00002
- Event Type
- Malfunction
- Date Received
- August 6, 2012
- Date of Event
- December 9, 2011
- Report Date
- February 16, 2012
- Manufacturer
- RADIUS MEDICAL TECHNOLOGIES, INC.
- Product Code
- MMX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT WAS REPORTED TO THE DISTRIBUTOR TWO MONTHS AFTER IT WAS TO HAVE OCCURRED. THE PRODUCT WAS NOT RETURNED, NOR WAS ADD'L INFO PROVIDED TO COMPLETE AN EVALUATION OF THE DEVICE AND PROCEDURAL CIRCUMSTANCES. IT IS NOT CLEAR FROM THE INFO PROVIDED WHAT THE ACTUAL PROCEDURAL AND PT OUTCOMES WERE.
Description of Event or Problem · 1
EVENT OCCURRED IN (B)(6) BUT WAS NOT REPORTED UNTIL (B)(4). PHYSICIAN HAS NOT RESPONDED TO F/U REQUESTS FOR INFO OR RETURN OF THE PRODUCT. PHYSICIAN WAS USING A SNARE TO RETRIEVE AN OBJECT. THE SNARE PERFORM W/O ANY DIFFICULTIES TO CAPTURE THE OBJECT, HOWEVER DURING REMOVAL OF THE OBJECT FROM THE PT, THE SNARE FRACTURED AND PART OF THE SNARE WAS LEFT IN THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXPRO ELITE SNARE | RETRIEVAL DEVICE | MMX | RADIUS MEDICAL TECHNOLOGIES, INC. | 6600-035 | 11W-17334 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |