MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2009-10-01 for MOLLRING CUTTER MRC4407 manufactured by Lemaitre Vascular, Inc..
[1235417]
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.
Patient Sequence No: 1, Text Type: D, B5
[8287886]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220948-2009-00008 |
| MDR Report Key | 1493419 |
| Report Source | 01,07 |
| Date Received | 2009-10-01 |
| Date of Report | 2009-09-30 |
| Date of Event | 2009-09-10 |
| Date Mfgr Received | 2009-09-10 |
| Device Manufacturer Date | 2008-03-01 |
| Date Added to Maude | 2011-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 63 SECOND AVENUE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7812212266 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOLLRING CUTTER |
| Generic Name | MOLLRING CUTTER |
| Product Code | DWX |
| Date Received | 2009-10-01 |
| Returned To Mfg | 2009-09-23 |
| Catalog Number | MRC4407 |
| Lot Number | MOL1014 |
| Device Expiration Date | 2010-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEMAITRE VASCULAR, INC. |
| Manufacturer Address | 63 SECOND AVENUE BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2009-10-01 |