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

Model Number e1651-84

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

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

Event Date 02/25/2020

Event Type  malfunction  

Manufacturer Narrative

We have received the complaint device for evaluation and we have confirmed the reported incident.We observed the balloon had ruptured and the proximal ligature has slipped from its intended position.We did not observe any necking of the extrusion lumen.During the follow-up conversation with the contact person at the hospital, we learned that the device was not checked prior to the procedure.Surgeon had to pull the catheter to remove the undeflated balloon.While doing so, the balloon ruptured.Based on our investigation, it is possible that the balloon was not tied sufficiently to the catheter shaft.It is also possible that some anatomical (calcification or stenosis in the lesion area) or procedural factors (use of excessive force to remove the thrombus) may have contributed to the balloon failure.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.Based on this incident and similar incidents reported by other users, we are preparing to initiate a recall on certain lots of lemaitre 5 french plus over-the -wire embolectomy catheters.There was no injury to the patient as the result of this incident.

Event Description

During a thrombectomy procedure, the balloon of an over-the-wire embolectomy catheter failed to deflate.The balloon burst when surgeon attempted to remove the undeflated balloon from the patient's vessel.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: 9875471
• MDR Text Key: 202540214
• Report Number: 1220948-2020-00040
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00840663100859
• UDI-Public: 00840663100859
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse Practitioner
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/24/2020

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 Model Number: e1651-84
• Device Catalogue Number: E1651-84
• Device Lot Number: OTW4193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2019
• 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