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

Model Number	e2012-11
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation.When we attempted to inflate the internal carotid balloon with saline, we observed a leak at the proximal end of the safety balloon.We observed a cut on this end of the balloon that resulted in this device failure.Based on our device evaluation, it is likely that this device was improperly handled by the user at the hospital.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 for devices from this lot.Device was not used in the patient.Procedure was completed using another f3 shunt that they had in stock.
Event or Problem Description
During pre-use check, when surgeon attempted to inflate the internal carotid balloon with saline, he observed a leakage at the safety balloon.Device was not used 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
• MDR Report Key: 9826199
• Report Number: 1220948-2020-00032
• Device Sequence Number: 654386
• Product Code: MJN
• UDI-Device Identifier: 00840663101290
• UDI-Public: 00840663101290
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/12/2020

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: e2012-11
• Device Catalogue Number: E2012-11
• Device Lot Number: PFT3608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1