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

Catalog Number	1651-84
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation and we have confirmed the reported incident.We observed that the balloon in this catheter had a circumferential rupture and was missing about 5 mm of its balloon piece at its middle region.No other defects were noted on this device.Surgeon had tested the balloon functionality before use and found it be operational.During follow-up with the nurse, we learned that the device was used to pull a fresh thrombus.The balloon ruptured during first pass.Nurse could not confirm the level of calcification that was present in the patient's vessel where this device was operated.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.Our quality control inspector had also performed a pull test on a sample of the catheters from this lot number during in-process inspection.All of these units passed the qc requirements and performed as intended when tested to their validated force.Based on our observation of the returned device, it is 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 rupture.Our ifu appropriately warns the users about the risks that could occur with the use of the embolectomy catheter including the risk of balloon rupture due to exposure to calcified plaque or overinflated balloon.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.There was no injury to the patient as the result of this incident.Please note that we have submitted manufacturer's incident report# 1220948-2019-00002, 1220948-2019-00003 and 1220948-2019-00004 related to 3 other otw catheters malfunction that occurred following this event.The balloons in all of these catheters ruptured during pre-use check.
Event or Problem Description
During thrombectomy, the balloon of over-the-wire embolectomy catheter ruptured when surgeon attempted to remove the clot by pulling it through the inflated balloon of this catheter.There was no injury to the patient as the result of this incident.This is report 1 of 4.

• Brand Name: OVER-THE-WIRE EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 9548998
• Report Number: 1220948-2020-00001
• Device Sequence Number: 3603016
• Product Code: DXE
• UDI-Device Identifier: 00840663100859
• UDI-Public: 00840663100859
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K022145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/03/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2022
• Device Catalogue Number: 1651-84
• Device Lot Number: OTW3366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1