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

Model Number 1651-44

Device Problem Deflation Problem (1149)

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

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

We have not received the complaint device for evaluation since it was discarded by the user facility.Hence, we could not conclusively determine the root cause of the incident.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 a similar nature for devices from this lot.The malfunction was detected during pre-use check.Surgeon used another lemaitre over-the-wire embolectomy catheter for the procedure.

Event Description

During pre-use check, after user inflated the balloon of the lemaitre over-the-wire embolectomy catheter, he was unable to deflate the balloon.The malfunction was detected during pre-use check.This device was not used for the procedure.

• Brand Name: LEMAITRE 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 ; 7212212266
• MDR Report Key: 11089877
• MDR Text Key: 245080413
• Report Number: 1220948-2020-00124
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00840663100675
• UDI-Public: 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: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/29/2020

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: 06/10/2020
• Device Model Number: 1651-44
• Device Catalogue Number: 1651-48
• Device Lot Number: OTW4495
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/29/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/10/2020
• 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