MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC PRUITT F3 CAROTID SHUNT

Model Number	1651-84
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the complaint device for investigation.Hence, we could not conclusively determine the root cause of the incident.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.The alleged defect was detected during pre-use check.The complaint device was not used for the procedure.
Event or Problem Description
The common carotid balloon ruptured during pre-use check.So, the user used another shunt for the procedure.

• Brand Name: PRUITT F3 CAROTID SHUNT
• Common Device Name: CAROTID SHUNT
• 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: 12980575
• Report Number: 1220948-2021-00112
• Device Sequence Number: 4789996
• Product Code: MJN
• UDI-Device Identifier: 00840663100743
• UDI-Public: 00840663100743
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/10/2021

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: 01/28/2025
• Device Model Number: 1651-84
• Device Catalogue Number: E2012-10
• Device Lot Number: PFT3818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown