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

Catalog Number 1651-88

Device Problems Deflation Problem (1149); Nonstandard Device (1420)

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

Event Date 05/20/2020

Event Type  malfunction  

Manufacturer Narrative

We have not received the complaint device for evaluation since the device has been discarded by the user facility.During our follow-up investigation, we learned that the device was checked before the procedure.Surgeon found the catheter to be operational during pre-use check.The malfunction occurred while removing the fresh clot from patient's av graft situated in his right hand.Surgeon was able to remove the catheter using a sheath and a guidewire.No surgical intervention was needed.There was no injury to the patient as the result of this incident.The arterial embolectomy catheter is not recommended for the removal of fibrous, adherent or calcified material ( eg.Chronic clot, atherosclerotic plaque ).This catheter is not designed to withstand the additional pull force needed to remove these materials.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.Based on similar incidents previously reported by other users, we have already initiated a recall on certain lots of lemaitre 5 french plus over-the -wire embolectomy catheters.The complaint lot is included in the list of recall lots.

Event Description

During declotting of av graft, the balloon of an over-the-wire embolectomy catheter failed to deflate.Surgeon removed the catheter using a sheath and a guidewire.There was no injury to the patient as the result of this incident.

• Brand Name: LEMAITRE OVER-THE-WIRE EMBOLECTOMY CATHETER
• Type of Device: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington, ma
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second ave; burlington, ma
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, ma ; 2212266152
• MDR Report Key: 10075698
• MDR Text Key: 192156427
• Report Number: 1220948-2020-00061
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K022145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1651-88
• Device Lot Number: OTW4255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2020
• Initial Date FDA Received: 05/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2019
• 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