MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-25 for MULTITASC DISSECTION/TRANSECTION DEVICE 4500-05 manufactured by Lemaitre Vascular, Inc..
[98531029]
We have received the device for evaluation. We have confirmed the reported incident. One of the shaft near to the ring was found to be bent. From the sales rep, we were able to confirm that the atheromatous core was heavily calcified. As stated in the ifu, we do not recommend using the multitasc device in patients with sever calcification. It is possible that the calcified core was hard enough to cause the shaft to bent during dissection step. An amount of eight (8) out of 9 units manufactured from this lot has been sold. We have not received any other complaints related to a similar issue from other customers for this lot or any other lots hence, we consider this to be an isolated incident. Sales rep. Also confirmed that the physician lost the core before even the device was bent. So, he extended the arteriotomy to gain access to the core and then untwisted the core. When they removed the core, they found out the device was stuck because of an accordian effect of the broken core. There was no injury to the patient as the result of this incident.
Patient Sequence No: 1, Text Type: N, H10
[98531030]
During remote endarterectomy, while dissecting an atheromatous core from the vessel wall in the sfa, physician noticed that the handle near the ring had bent. Surgeon had to extend the arteriotomy to gain access to the core since it was pushed down.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2018-00006 |
| MDR Report Key | 7219909 |
| Date Received | 2018-01-25 |
| Date of Report | 2017-01-25 |
| Date of Event | 2017-12-26 |
| Date Mfgr Received | 2017-12-26 |
| Device Manufacturer Date | 2016-02-03 |
| Date Added to Maude | 2018-01-25 |
| 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 |
| 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 | MULTITASC DISSECTION/TRANSECTION DEVICE |
| Generic Name | INTRALUMINAL ARTERY STRIPPER |
| Product Code | LXA |
| Date Received | 2018-01-25 |
| Returned To Mfg | 2018-01-15 |
| Catalog Number | 4500-05 |
| Lot Number | MMD1129 |
| 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 | 2018-01-25 |