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

Model Number 1651-44

Device Problem Separation Problem (4043)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2022

Event Type  malfunction  

Event Description

It was reported that during the pre-use check, the tuftex otw embolectomy catheter balloon came off from the catheter.No patient was involved.

Manufacturer Narrative

The complaint device was received for evaluation and the reported event was confirmed.The balloon was not attached to the device and the ligatures that fasten the balloon appeared to have slipped off from the catheter.This issue is a result of a manufacturing error during assembly/fastening of the balloon to the catheter.The lot history record for the device was reviewed, no issues were found during manufacturing or packaging that would cause or contribute to the reported event.There have not been any similar reports for product from this lot.This appears to be an isolated incident.

• Brand Name: TUFTEX 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: jeffrey oddy ; 63 second ave; burlington, MA 01803 ; 7814251682
• MDR Report Key: 16195168
• MDR Text Key: 308953970
• Report Number: 1220948-2023-00003
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00840663100675
• UDI-Public: (01)00840663100675
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2023

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 Model Number: 1651-44
• Device Catalogue Number: 1651-44
• Device Lot Number: OTW4847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2022
• 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