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

Catalog Number	2012-10
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the device for evaluation.However, we were able to observe the reported incident on the pictures that were provided to us.We observed a leakage at the safety balloon when liquid was injected into the inflation arm of the internal carotid balloon.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 we do conduct 100% inspection on each device and test them for balloon functionality.At this time, we are inconclusive about the root cause of this failure since we have not yet received it for evaluation.We currently have a corrective and preventive action (capa) open to address this issue and prevent them from reoccurring.
Event or Problem Description
During pre-use check, when surgeon attempted to inflate the internal carotid balloon with saline, it failed to inflate.He observed a liquid leakage from the safety balloon that resulted in this device malfunction.Device was not used for the 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: 9324140
• Report Number: 1220948-2019-00151
• Device Sequence Number: 2769015
• Product Code: MJN
• UDI-Device Identifier: 00840663100606
• UDI-Public: 00840663100606
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K051067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/14/2019

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: 01/28/2024
• Device Catalogue Number: 2012-10
• Device Lot Number: PFT3545
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1