MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. PRUITT F3 CAROTID SHUNT; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Catalog Number	2013-10
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation and we have confirmed the reported incident.When we attempted to inflate the safety balloon with saline, a leak on the distal (lower) side of the safety balloon joint was observed.There was no hole observed in the balloon.The root cause of the issue was determined to be manufacturing error during balloon assembly process- not enough adhesive was applied during bonding the balloon to the shunt inflation arm.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.Please note that our manufacturing team does conduct 100% inspection on each device and test them for balloon functionality.However, it is possible that the defect was accidentally missed during the inspection process.The leakage was detected during pre-use check.Procedure was completed using another f3 shunt they had in stock.
Event or Problem Description
Surgeon detected a leakage on the safety balloon during pre-use check.So, surgeon used another f3 shunt for the carotid endarterectomy procedure.

• Brand Name: PRUITT F3 CAROTID SHUNT
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 8545785
• Report Number: 1220948-2019-00047
• Device Sequence Number: 2049308
• Product Code: MJN
• UDI-Device Identifier: 00840663101320
• UDI-Public: 00840663101320
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2019

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: 07/28/2023
• Device Catalogue Number: 2013-10
• Device Lot Number: PFT3448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1