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

Catalog Number 2013-10

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

We have not received the device for evaluation.Hence, we could not conclusively determine the root cause of this issue.The function of the safety balloon is to prevent the internal carotid artery from over-inflating in the artery by diverting the pressure into the safety balloon in case the internal carotid balloon is over-inflated or over-pressurized in the artery.If the surgeon tried to inflate the internal carotid balloon too quickly or used excessive volume of saline to inflate the internal carotid balloon, this can lead to the safety balloon activation.However, it is highly unlikely for the safety balloon to burst if the surgeon inflated it with only 0.25 ml of saline as the safety balloon is able to hold more than 0.25 ml of saline.It is possible that the surgeon used more than the recommended volume of saline to inflate the internal carotid balloon.Another condition that can result in this issue is when the surgeon inflated the internal balloon too quickly with the safety sleeve over the safety balloon.As a result, this can cause premature activation of safety balloon prior to the internal carotid balloon and since the safety balloon is covered in the sleeve, this can burst the safety balloon.Please note that the safety balloon resides outside of the patient's vessel and does not come in contact with the patient's artery at anytime during the procedure.Our ifu properly instructs user to slowly inflate the internal carotid balloon with up to 0.25 ml of sterile saline and not to place the movable sleeve over the external safety balloon while inflating the internal carotid balloon.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.Therefore, we believe that it was an isolated incident.

Event Description

During a carotid endarterectomy, the safety balloon burst when the surgeon attempted to inflate in the internal carotid artery.As a result, the balloon could not occlude the internal carotid artery.This incident resulted in significant bleeding and the surgeon had to continue the operation without a shunt which presented a neurological risk to the patient.The procedure time was increased by 10 minutes as a result of this incident.The surgeon was able to complete the procedure without any further complications.

Event Description

During a carotid endarterectomy procedure, the safety balloon burst (located outside the patient ) when the surgeon attempted to inflate the internal carotid balloon.As a result, the internal carotid balloon could not occlude the internal carotid artery.Surgeon deeded to continue the operation without a shunt.There was no injury to the patient as the result of this incident.

Manufacturer Narrative

We have received the complaint device for evaluation.However, we did not observe any safety balloon burst as reported by the surgeon in the incident report form.When we attempted to inflate the safety balloon with saline, a leak at the distal ( lower ) end of the safety balloon joint was observed.There was no hole observed in the balloon.The root cause of the issue was determined to be a manufacturing error during balloon assembly process not enough adhesive was applied during bonding the balloon to the shunt arm.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.Please note that our manufacturing team does conduct 100% inspection on each device and test them for balloon functionality.However, it is possible that the defect was accidentally missed during the inspection process.Based on our risk documents, no corrective action is required at this time.The current rate of occurrence is within our expected rate of occurrence.

• Brand Name: PRUITT F3 CAROTID SHUNT
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 8336935
• MDR Text Key: 139344109
• Report Number: 1220948-2019-00011
• Device Sequence Number: 1
• Product Code: MJN
• UDI-Device Identifier: 00840663101252
• UDI-Public: 00840663101252
• Combination Product (y/n): N
• PMA/PMN Number: K051067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2023
• Device Catalogue Number: 2013-10
• Device Lot Number: PFT3400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 02/13/2019
• Supplement Dates Manufacturer Received: 01/14/2019
• Supplement Dates FDA Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1