FDA Adverse Event
Other
Summary report: N
MOLLRING CUTTER
MDR report key: 1493419
·
Received October 1, 2009
Report
- Report Number
- 1220948-2009-00008
- Event Type
- Other
- Date Received
- October 1, 2009
- Date of Event
- September 10, 2009
- Report Date
- September 30, 2009
- Manufacturer
- LEMAITRE VASCULAR, INC.
- Product Code
- DWX
- PMA / PMN Number
- K950813
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS EVALUATED AND WE ARE ABLE TO CONFIRM THAT DISTAL RING WAS DETACHED AND A CLEAN BREAK WAS SEEN. THE EVAL WAS INCONCLUSIVE ON THE ROOT CAUSE OF THE DEVICE FAILURE. HOWEVER, THE SUPPLIER WAS NOTIFIED. THE DEVICE HISTORY RECORDS FOR LOT MOL1014 REVIEW DID NOT REVEAL ANY DISCREPANCY TO THE COMPLAINT EVENT DURING EITHER THE MANUFACTURING OR THE PACKAGING PROCESS. THERE ARE NO UNRESOLVED ISSUES.
Description of Event or Problem · 1
DISTAL RING BLADE OF MOLLRING CUTTER BROKE OFF DURING THE CUTTING MANEUVER AND REMAINED IN THE VESSEL. MOLLRING BLADE LEFT IN THE ARTERY BECAUSE IT DOES NOT FORESEE ANY DANGER TO THE PT. NO CHANGE IN PT TREATMENT WAS MADE. PT IS DOING OKAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MOLLRING CUTTER | MOLLRING CUTTER | DWX | LEMAITRE VASCULAR, INC. | MOL1014 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |