MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. MULTITASC DISSECTION/TRANSECTION DEVICE; INTRALUMINAL ARTERY STRIPPER

Catalog Number 4500-05

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/26/2017

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: MULTITASC DISSECTION/TRANSECTION DEVICE
• Type of Device: INTRALUMINAL ARTERY STRIPPER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR; 63 second ave; burlington MA 01803
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 7219909
• MDR Text Key: 98531029
• Report Number: 1220948-2018-00006
• Device Sequence Number: 1
• Product Code: LXA
• UDI-Device Identifier: 00840663105847
• UDI-Public: 00840663105847
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/28/2023
• Device Catalogue Number: 4500-05
• Device Lot Number: MMD1129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention