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

Catalog Number	E2013-10
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/20/2019
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 blue stopcock joint when we attempted to inject liquid into the common carotid balloon.Upon further inspection of the joint, we detected an inadequate glue joint on the stopcock area.Internal carotid balloon inflated and deflated properly.The root cause of the issue was determined to be an operator error- not enough glue was applied on the stopcock joint during the assembly process.We currently have a corrective and preventive action (capa) open to address this issue and prevent them from reoccurring.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.The malfunction was detected during pre-use check.Surgeon used another f3 shunt for the procedure.
Event or Problem Description
During pre-use check, when the user attempted to inflate the common carotid balloon with saline, he detected a leak at a joint between the stopcock and the common carotid balloon inflation arm.

• 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: 9047494
• Report Number: 1220948-2019-00130
• Device Sequence Number: 17076434
• Product Code: MJN
• UDI-Device Identifier: 00840663101320
• UDI-Public: 00840663101320
• Combination Product (Y/N): N
• 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): 09/12/2019

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: 10/28/2018
• Device Catalogue Number: E2013-10
• Device Lot Number: PFT3500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1