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

Catalog Number 1651-44

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

We have received the complaint device for evaluation and we have confirmed the reported incident.The balloon had dislodged from its catheter shaft.The dislodged balloon had its distal and proximal ligature intact on it.We did not observe any necking of the extrusion.We have conducted a lot history review for this lot number and did not find any issues noted in the manufacturing or packaging process that could be related to this issue.All qc tests passed their requirements.Further, we have not received any other complaints of a similar nature for devices from this lot.At this time, we could not conclusively determine the root cause of the defect.It is possible that the tension or the amount of glue applied underneath the balloon during winding of the threads to the lumen of the catheter was not strong enough to prevent the ligature from slipping from its position.Device was tested by the surgeon before use and was found to be functional.During the procedure, surgeon had attempted to remove the thrombus multiple times before encountering the issue.It is also possible that the tortuous anatomy of the patient, calcified plaque that were present in the patient's vessel, and the tension on the device during the procedure could have also led to this failure.Please note that our manufacturing team does perform 100% inspection on each device to ensure that the ligature is properly bound to the shaft of the catheter.The arterial embolectomy catheter is not recommended for the removal of fibrous, adherent or calcified material ( eg.Chronic clot, atherosclerotic plaque ) since this catheter is not designed to withstand the additional pull force needed to remove these materials.Surgeon was able to remove the dislodged balloon from the patient's vessel.There was no injury to the patient as a result of this incident.

Event Description

During thrombectomy, the balloon dislodged from the catheter shaft.Surgeon was able to retrieve the balloon from the patient's vessel.There was no injury to the patient as the result of this incident.

• 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: 8818446
• MDR Text Key: 152075581
• Report Number: 1220948-2019-00090
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00840663100675
• UDI-Public: 00840663100675
• Combination Product (y/n): N
• PMA/PMN Number: K022145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1651-44
• Device Lot Number: OTW3965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2018
• 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
• Patient Outcome(s): Required Intervention