MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-11-13 for MOLLRING CUTTER MRC4405 manufactured by Lemaitre Vascular.
[989313]
After deploying the cutting blades of the mollring cutter, the surgeon closed the blades. The blades did not appear to fully close during fluoroscopy, and when attempting to pull the mollring cutter back in order to remove the transected plaque core, the fluoroscopy indicated that one of the cutting blades had broken off the device, and was still in the artery. Another incision was made and plaque was removed. The physician used an endohelix device to remove the mollring blade. It was the physician's first time using the device, and deployed the wires behind the core rather than around the core. He made another attempt to go around the core, and perforated the artery wall. The interventional radiologist used a stent to restore the flow, and made the recommendation to leave the mollring blades in the artery because he does not foresee any danger to the pt. Pt is doing okay.
Patient Sequence No: 1, Text Type: D, B5
[8232711]
The device was evaluated, and we were able to confirm that distal ring was detached and a clean break was seen. The eval of the complaint device was inconclusive on the root cause of the device failure. The device history records for lot mol1001 was examined. The 100% incoming inspection of the ring alignment and visual inspection for damage or cracks was completed in accordance to the procedure with passing results. This is the first complaint we have seen of this in 2008, therefore, this is an isolated incident. This is the initial and final report for this complaint. If there is any further info that is found concerning this complaint, this will be sent in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220948-2008-00011 |
| MDR Report Key | 1239100 |
| Report Source | 05 |
| Date Received | 2008-11-13 |
| Date of Report | 2008-11-06 |
| Date of Event | 2008-10-29 |
| Date Mfgr Received | 2008-10-30 |
| Device Manufacturer Date | 2008-01-01 |
| Date Added to Maude | 2009-09-10 |
| 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 2ND AVENUE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7812212266 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOLLRING CUTTER |
| Generic Name | MOLLRING CUTTER |
| Product Code | DWX |
| Date Received | 2008-11-13 |
| Returned To Mfg | 2008-10-30 |
| Catalog Number | MRC4405 |
| Lot Number | MOL1001 |
| Device Expiration Date | 2009-12-31 |
| 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 |
| Manufacturer Address | 63 2ND AVENUE BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-11-13 |