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

Model Number	e2013-10
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During pre-use check, the user observed the balloons of the pruitt f3 carotid shunt were dry.She observed the saline was leaking from the balloons when she attempted to inflate the balloons.So, a second pruitt f3 carotid was opened and prepared for the case.
Additional Manufacturer Narrative
We have received the complaint device for evaluation and we were able to confirm the reported malfunction.We observed signs of degradation on both the internal and common carotid balloon.As stated in the ifu, natural rubber latex is affected by environmental conditions, so we always recommend storing these products properly to achieve optimum shelf life.The product should be stored in a cool dark area away from fluorescent lights, sunlight, and chemical fumes.The products should be stored in the provided aluminum pouches that help to prevent the balloons from premature deterioration.The foil pouches should only be removed immediately prior to use.We were able to confirm that the user followed the instructions as stated in the ifu.At this time, we could not conclusively determine the root cause of the incident.We have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue.All qc tests passed their requirements.Further, we have not received any other complaints of a similar nature from other customers for devices from this lot.The malfunction was detected during the pre-use check.The surgeon used another f3 carotid shunt for the procedure.

• Brand Name: PRUITT F3 CAROTID SHUNT
• Common Device Name: CAROTID SHUNT
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; lemaitre vascular, inc.; 63 second ave 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: 15125046
• Report Number: 1220948-2022-00067
• Device Sequence Number: 5736789
• Product Code: MJN
• UDI-Device Identifier: 00840663101320
• UDI-Public: 00840663101320
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2022

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: 07/28/2025
• Device Model Number: e2013-10
• Device Catalogue Number: E2013-10
• Device Lot Number: PFT3907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown