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	09/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation could not be performed since the device was not returned to us by the hospital.Hence, we could not conclusively determine the root cause of the issue at this time.The complaint device lot history records review did not reveal any discrepancies related to the complaint event during either the manufacturing or packaging processes.We also have not received any other complaints for devices from this lot.At this time, we are inconclusive about the root cause of this issue.Device was tested before use and was found to be operational.We currently have a corrective and preventive action (capa) open to address this issue.There was no injury to the patient as a result of this incident.
Event or Problem Description
The surgeon experienced resistance while removing one of the arms of the shunt after the carotid endarterectomy procedure.He was able to completely remove the arm without any vessel injury.He observed the balloon on this arm of the shunt had only partially deflated, resulting in this issue.
Additional Manufacturer Narrative
We have received the device for evaluation.However, we were unable to confirm the reported incident.The common carotid balloon inflated and deflated properly.We were unable to inflate the internal carotid balloon since there was a leakage at the inflation arm to main arm joint.We observed that the end of the inflation lumen had separated from the inflation hole in the main arm.When we injected liquid through the stopcock, water exited from the separated end of the inflation arm.Also, when we inflated the internal carotid balloon using a needle syringe through the inflation hole in the main tube, we were able to inflate the balloon symmetrically and deflate it without any issue.It is possible that the lumen separated as a result of excessive force used by the user to remove the internal carotid balloon that was trapped in the patient's vessel.The complaint device lot history records review did not reveal any discrepancies related to the complaint event during either the manufacturing or packaging processes.We also have not received any other complaints for devices from this lot related to a similar incident.Device was tested before use and was found to be operational.At this time, we are inconclusive about the root cause of this issue.We currently have a corrective and preventive action (capa) open to address this issue.
Event or Problem Description
The surgeon experienced resistance while removing one of the arms of the shunt after the carotid endarterectomy procedure.He was able to completely remove the arm without any vessel injury.He observed that the balloon on this arm of the shunt had only partially deflated, resulting in this issue.This is a follow-up report of manufacturer's incident report# 1220948-2018-00078 that was submitted on 10/10/2018.

• 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: 7952762
• Report Number: 1220948-2018-00078
• Device Sequence Number: 19025076
• Product Code: MJN
• UDI-Device Identifier: 00840663101245
• UDI-Public: 00840663101245
• 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): 11/20/2018

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: 01/25/2018
• Device Catalogue Number: 2012-12
• Device Lot Number: PFT3333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1