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	07/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the complaint device for investigation since the device was discarded by the user.Without the returned device, we remain inconclusive about the root cause of this malfunction.The incident occurred on (b)(6) 2020.However, the incident was reported to the lemaitre sales rep.Only on february 08, 2021.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.The malfunction was detected during pre-use check.Device was not used for the procedure.Please note that we have also reported another case of lemaitre aortic occlusion catheter balloon malfunction (manufacturer report# 1220948-2021-00021) that was reported to us by the same hospital.
Event or Problem Description
During pre-check, the balloon of the lemaitre aortic occlusion catheter ruptured upon inflation.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: 11457079
• Report Number: 1220948-2021-00022
• Device Sequence Number: 4189172
• 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): 03/10/2021

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: 12/28/2023
• Device Model Number: 2107-81
• Device Catalogue Number: 2107-81
• Device Lot Number: OLC1047
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1