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

Model Number	e2013-10
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation and we have confirmed the reported incident.We observed a leakage at the white stopcock joint when we attempted to inject liquid into the internal carotid balloon.As a result, the internal carotid balloon failed to inflate.Upon further inspection of the joint, we observed an inadequate amount of glue at the stopcock joint.Common carotid balloon inflated and deflated properly.The root cause of the malfunction was determined to be a manufacturing operator error- not enough glue was applied on the stopcock joint during the assembly process.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.We currently have a corrective and preventive action (capa) open to address this issue and prevent them from reoccurring.The malfunction was detected during pre-use check.This device was not used for the procedure.
Event or Problem Description
During pre-use check, when the surgeon attempted to inflate the internal carotid balloon with saline, the balloon did not inflate properly.The malfunction was detected during the pre-use check.The surgeon used another f3 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
• MDR Report Key: 11888564
• Report Number: 1220948-2021-00051
• Device Sequence Number: 16490781
• Product Code: MJN
• UDI-Device Identifier: 00840663101320
• UDI-Public: 00840663101320
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2021

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: 03/28/2025
• Device Model Number: e2013-10
• Device Catalogue Number: 2012-10
• Device Lot Number: PFT3874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1