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

Catalog Number	2012-12
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation could not be performed since the surgical team at the hospital have not yet returned the complaint device.So, at this time, we are unable to determine the exact root cause of this device failure.Device was checked before use and was found to be functional.Both balloons in this shunt worked properly throughout the entire endarterectomy procedure.It was after completion of the procedure, surgeon encountered this issue as he was unable to deflate the internal carotid balloon by aspirating the saline in the balloon.We reviewed the lot history records for this lot number and did not find any discrepancies that would contribute to this incident.Our complaint history analysis showed that no other similar complaints were found on this lot number.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.No further information was provided by the treating surgeon.Since the balloon operated properly during pre-use check and during use, it is possible that some anatomical or procedural factors may have contributed to this issue.
Event or Problem Description
After successfully completing the carotid endartectomy 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.After attempting multiple times, we was able to partially deflate the balloon and remove it from the patient's carotid artery.Common carotid balloon deflated properly.The surgical team had tested both balloons before the procedure and were found to be functional.No further intervention was needed.
Event or Problem Description
After successfully completing the carotid endartectomy 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.After attempting multiple times, he was able to partially deflate the balloon and remove it from the patient's carotid artery.Common carotid balloon deflated properly.The surgical team had tested both balloons before the procedure and were found to be functional.No further intervention was needed.
Additional Manufacturer Narrative
We have received the complaint device for evaluation.However, we were unable to confirm the reported incident.We were able to properly deflate the internal carotid balloon and common carotid balloon when they were inflated with 1.5 ml and 0.25 ml of saline, respectively.We did not notice any blockage or kinks in the inflation lumen that could have prevented the internal carotid balloon from deflating.We were unable to replicate the reported defect even when we tried to reproduce the failure by inserting both balloons in the test fixture.We have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue.All qc tests passed their requirements.Further, we have not received any other complaints of a similar nature for devices from this lot.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 as well as during our evaluation, it is possible that some anatomical factors may have led to this deflation issue.

• 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: 8573478
• Report Number: 1220948-2019-00050
• Device Sequence Number: 2353735
• Product Code: MJN
• UDI-Device Identifier: 00840663101238
• UDI-Public: 00840663101238
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2019

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: 08/28/2023
• Device Catalogue Number: 2012-12
• Device Lot Number: PFT3459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1