MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. OVER-THE-WIRE EMBOLECTOMY CATHETER

Catalog Number 1651-44

Device Problem Positioning Failure (1158)

Patient Problem No Information (3190)

Event Date 12/27/2018

Event Type  malfunction  

Manufacturer Narrative

We have not received the complaint device for evaluation.Hence, we could not conclusively determine the root cause of the defect.Our manufacturing team does conduct 100% inspection on each device and test them for balloon functionality.Each of the balloons are inflated with air using a syringe and then inspected to ensure balloons open concentric.It is possible that during manufacturing, the balloons were poorly assembled which led to non-concentric inflation of the balloon.Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.Further, we have not received any other complaints of similar nature for devices from this lot.Therefore, we believe that it was an isolated incident.This catheter was not used for the surgery.Procedure was completed using another catheter that they had in stock.

Event Description

During pre-use check, the balloon of the catheter did not inflate symmetrically.

• Brand Name: OVER-THE-WIRE EMBOLECTOMY CATHETER
• Type of Device: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 8279469
• MDR Text Key: 134903387
• Report Number: 1220948-2019-00008
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00840663100484
• UDI-Public: 00840663100484
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K022145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2024
• Device Catalogue Number: 1651-44
• Device Lot Number: OTW3845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2018
• Initial Date FDA Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2018
• 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