MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. LEMAITRE AORTIC OCCLUSION CATHETER

Model Number	2107-81
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the complaint device for investigation.Without the returned device, we remain inconclusive about the root cause of this malfunction.The device was used in a cadaver during an organ explant.Surgeon was able to explant the organ in a viable condition.However, surgeon needed to speed up the procedure since the entire procedure must be completed in less than 25 minutes.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.Please note that we have also submitted manufacturer incident report# 1220948-2021-00009 related to another lemaitre aortic occlusion incident that occurred during the same procedure.
Event or Problem Description
Surgeon used lemaitre aortic occlusion catheter (ref# 2107-81 lot# olc1059) on a deceased patient during organ explant.However, the balloon of this catheter deflated during the procedure.Despite the malfunction, surgeon was able to remove the organ successfully and just in time and as he was able to complete the entire procedure in less than 25 minutes.This is report 2 of 2.

• Brand Name: LEMAITRE AORTIC OCCLUSION CATHETER
• Common Device Name: OCCLUSION CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 11352882
• Report Number: 1220948-2021-00010
• Device Sequence Number: 3545412
• Product Code: MJN
• UDI-Device Identifier: 00840663101658
• UDI-Public: 00840663101658
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K132022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 02/19/2021

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: 05/28/2024
• Device Model Number: 2107-81
• Device Catalogue Number: 2107-81
• Device Lot Number: OLC1059
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1