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

Catalog Number	E2012-11
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation.However, we were unable to replicate the reported incident during our evaluation.We observed the inflation arm of the internal carotid balloon was cut and was missing its stopcock.When we attempted to inflate the internal carotid balloon using saline, we observed liquid leakage from its internal carotid balloon.It is likely the surgeon attempted to deflate the internal carotid balloon by puncturing the balloon and by cutting the inflation arm of the shunt.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.Our manufacturing team does conduct 100% inspection on each device and tests them for balloon functionality.Each balloon is inspected to ensure they inflate and deflate properly.Device was checked before use and was found to be functional.No further information was provided by the treating surgeon.At this time, we could not conclusively determine the root cause of this defect.Since the balloon operated properly during pre-use check, it is possible that some anatomical factors may have led to this deflation issue.There was no reported injury or any harm to the patient.Our engineering team has also addressed similar balloon deflation issues by improving the design of this product.The change involves the addition of inflation holes under the balloon and a change in the cut angle of the inflation arm, which will assist the balloons to inflate and deflate uniformly along their entire length.
Event or Problem Description
During the carotid endarterectomy procedure, the surgeon attempted to deflate the internal carotid balloon by aspirating the liquid inside the balloon using a syringe.However, he was unable to deflate the internal carotid balloon.The surgical team had tested both balloons before the procedure and both were found to be functional.

• 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: 8667744
• Report Number: 1220948-2019-00065
• Device Sequence Number: 13998892
• Product Code: MJN
• UDI-Device Identifier: 00840663101290
• UDI-Public: 00840663101290
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2023
• Device Catalogue Number: E2012-11
• Device Lot Number: PFT3466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention