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	06/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation.The common carotid balloon inflated and deflated properly when we inflated it was saline.We did not observe any leakage from the blue stopcock joint.However, when we attempted to inflate the internal carotid balloon with saline, we observed liquid leaking from proximal end of the safety balloon.The root cause of the issue was determined to be an operator error- not enough glue was applied on the safety balloon joint during 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 have made our manufacturing team aware of this issue and retrained them on glueing technique which we believe will prevent these issues from reoccurring.The malfunction was detected during pre-use check.Surgeon used another f3 shunt for the procedure.
Event or Problem Description
During pre-use check, user detected a leakage at the safety balloon when he attempted inflate the internal carotid balloon with saline.

• 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: 8745612
• Report Number: 1220948-2019-00085
• Device Sequence Number: 1668327
• Product Code: MJN
• UDI-Device Identifier: 00840663101320
• UDI-Public: 00840663101320
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/28/2019

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: 09/28/2023
• Device Catalogue Number: E2013-10
• Device Lot Number: PFT3479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1