MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06,07 report with the FDA on 2011-05-26 for MOLLRING CUTTER TRANSECTION DEVICE 4200-42 manufactured by Lemaitre Vascular.
[22094470]
The mollring device was used for endarterectomy procedure. The device was passed to the distal portion of the sfa, where it was intended to cut the plaque. The plaque was calcified distally. When dr (b)(6) pulled the white handle away from the blue to engage the cutter, the top cutting ring disengaged itself perpendicular to the bottom blade under fluoro. It was assumed that there was an issue with the cutter. The physician was unable to get the cutting rings to go back together, but he was able to remove the core. Upon inspection, the top ring was caught around the core. When the core was removed from the ring, it was found that the top ring had actually broken at the weld away from its shaft and had gotten stuck in the core. Patient is fine and the case was done successfully.
Patient Sequence No: 1, Text Type: D, B5
[22132190]
We have received the device for evaluation and were able to verify the failure. The top (proximal) ring welding evaluation did not reveal any problems during the manufacturing process - weld was done correctly. The root cause of the failure is inconclusive. It is possible the excessive force and/or calcified vessel contributed to the failure. Please note that we do not recommend the use of mollring cutter devices for cutting calcified material since it may damage the device (please reference lemaitre vascular, inc. Ifu precaution section for more details - see attachment). Please note that the patient is fine and the case was done successfully.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220948-2011-00004 |
| MDR Report Key | 2104796 |
| Report Source | 04,05,06,07 |
| Date Received | 2011-05-26 |
| Date of Report | 2011-04-15 |
| Date Mfgr Received | 2011-04-20 |
| Device Manufacturer Date | 2010-03-01 |
| Date Added to Maude | 2011-10-31 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOLLRING CUTTER TRANSECTION DEVICE |
| Generic Name | MOLLRING CUTTER |
| Product Code | DWX |
| Date Received | 2011-05-26 |
| Returned To Mfg | 2011-05-03 |
| Model Number | 4200-42 |
| Catalog Number | 4200-42 |
| Lot Number | MOL1055 |
| Device Expiration Date | 2012-02-29 |
| 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 | BURLINGTON MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-26 |