MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. PRUITT F3 CAROTID SHUNT

Catalog Number	2011-10
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	10/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have not received the complaint device for evaluation.Hence, we could not conclusively determine the root cause of the failure.We have received a picture of the reported complaint device from the user.In the picture, we observed an inflated internal carotid balloon while the common carotid balloon was observed to be deflated.We could not confirm the reported defect in the provided picture.During our follow-up with the surgeon, we learned that he had inspected both balloons during pre-use check and found them to be operational.The common carotid balloon was inserted approximately 2 cm into the common carotid artery from the arteriotomy and did not pass any atheromatous section since the stenosis was observed to be in the internal carotid artery.Balloon burst when surgeon attempted to inflate the common carotid balloon with 1.25 ml fo saline.Approximately 3 ml of blood was lost due to bleeding.Surgeon then clamped the common carotid artery and continued with the procedure.Procedure completed successfully within 20-25 minutes after the occurrence of this incident.Surgeon confirmed that there were no any balloon fragments left over in the patient's artery.Cerebral function was monitored throughout the procedure and surgeon confirmed that the patient did not experience any neurological deficit as a result of this incident.We were also able to confirm that this device was stored in the room temperature and the pouch was just removed prior to the surgery.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 test them for balloon functionality.As stated in the ifu, we recommend exercising caution when encountering extremely diseased vessels.Arterial rupture or balloon failure due to sharp calcified plaque may occur.The possibility of balloon rupture must be taken into account when considering the risks involved in the endarterectomy procedure.At this time, we could not conclusively determine the root cause of the failure.It is possible that some anatomical feature ( sharp calcified plaque ) or procedural factors ( use of clamps over the balloon ) may have contributed to the balloon rupture since the balloon operated properly during pre-use check.
Event or Problem Description
At a beginning of a carotid endarterectomy (cea) procedure, using a f3 carotid shunt, when surgeon attempted to occlude the common carotid artery by inflating the common carotid balloon with saline, he observed the balloon was leaking and was unable to occlude the common carotid artery resulting in blood leakage from the artery.Surgeon clamped the common carotid artery and completed the procedure without any further complications.Surgeon inspected the balloons during pre-use check and found them to be operational.

• Brand Name: PRUITT F3 CAROTID SHUNT
• Common Device Name: CAROTID SHUNT
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 9377525
• Report Number: 1220948-2019-00159
• Device Sequence Number: 3104349
• Product Code: MJN
• UDI-Device Identifier: 00840663101191
• UDI-Public: 00840663101191
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 11/26/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2023
• Device Catalogue Number: 2011-10
• Device Lot Number: PFT3434
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/26/2019
• 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