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

Model Number	2107-81
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2021
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.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 similar complaints from this lot number.Please note that we have also submitted manufacturer's incident report# 1220948-2021-00013 related to another similar lemaitre aortic occlusion catheter balloon malfunction that occurred at the same hospital.
Event or Problem Description
During pre-check, when user inflated the balloon of the lemaitre aortic occlusion catheter with liquid, he observed a leakage from the balloon.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: 11375794
• Report Number: 1220948-2021-00014
• Device Sequence Number: 17089162
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/23/2021

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: 04/28/2024
• Device Model Number: 2107-81
• Device Catalogue Number: 2107-81
• Device Lot Number: OLC1055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1