MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-16 for ENDORE MOLLRING CUTTER TRASECTION DEVICE 4200-41 manufactured by Lemaitre Vascular, Inc..
[108858841]
We have received the device for evaluation and confirmed the reported incident. We found that when the device was closed, the two rings do not overlap over each other as one of the hoop was found to be slightly bent. As a result, when removing the core, physician could have experienced difficulty/resistance when passing the rings through a narrower section of the vessel. It is also possible that the tortuous anatomy of the patient, calcified plaque if present in the patient's vessel and excessive tension on the device while pulling the core could also have aided to this failure. As stated in our ifu, this device is not designed to cut calcified material. Attempted transection of such material may damage the mollring cutter transection device. We have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue. All qc tests passed their requirements. Further, we have not received any other complaints of similar nature for devices from this lot. We therefore believe this is an isolated incident. There was no injury to the patient as the result of this incident. Physician was able to retrieve the device and the atheromatous core using a lemaitre endohelix device.
Patient Sequence No: 1, Text Type: N, H10
[108858842]
During remote endarterectomy of sfa, after transecting the atheromatous core using a mollring cutter transection device, physician tried to extract the core out from the patient's vessel. However, the device was stuck midway in the thigh. Physician then had to use endohelix retrieval device to remove the core and the device from the patient's vein.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2018-00031 |
| MDR Report Key | 7519079 |
| Date Received | 2018-05-16 |
| Date of Report | 2018-05-16 |
| Date of Event | 2018-04-17 |
| Date Mfgr Received | 2018-04-17 |
| Device Manufacturer Date | 2015-03-28 |
| Date Added to Maude | 2018-05-16 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PRAGYA THIKEY |
| Manufacturer Street | 63 SECOND AVE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7812212266 |
| Manufacturer G1 | LEMAITRE VASCULAR, INC. |
| Manufacturer Street | 63 SECOND AVE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01803 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ENDORE MOLLRING CUTTER TRASECTION DEVICE |
| Generic Name | STRIPPER, ARTERY, INTRALUMINAL |
| Product Code | DWX |
| Date Received | 2018-05-16 |
| Returned To Mfg | 2018-05-11 |
| Catalog Number | 4200-41 |
| Lot Number | MOL1137 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEMAITRE VASCULAR, INC. |
| Manufacturer Address | 63 SECOND AVE BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-16 |