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

Model Number e2012-10

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

We have received the complaint device for evaluation.We observed the both ends of the extrusion lumen were cut.We were able to irrigate both lumens.We then clamped both ends of the extrusion lumen and inflated the balloons.The internal carotid balloon as well as the common carotid balloon inflated and deflated properly.During our device evaluation, we were not able to confirm any malfunction with this device.During our follow-up investigation, we were informed that the shunt was being used in conjunction with the tcar stent procedure.We were informed that the end of the extrusion lumen of the common carotid balloon may have been occluded because it was too close to the clavicle.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.There was no harm to the patient because of this incident.

Event Description

During a carotid endarterectomy with tcar stent occlusion, the surgeon was unable to properly inflate the common carotid balloon and establish a blood flow in the shunt.However, when he deflated the balloon, he was able to get a blood flow.After completing the procedure, he removed the device from the patient's vessel.He saw a bend in the extrusion lumen, between the end of the shunt and the balloon.

• Brand Name: PRUITT F3 CAROTID SHUNT
• Type of Device: CAROTID SHUNT
• Manufacturer (Section D): LEMAITRE VASCULAR, INC; 63 second ave; burlington MA 01803
• MDR Report Key: 12558054
• MDR Text Key: 282329453
• Report Number: 1220948-2021-00088
• Device Sequence Number: 1
• Product Code: MJN
• UDI-Device Identifier: 00840663101283
• UDI-Public: 00840663101283
• 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,health
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: e2012-10
• Device Catalogue Number: E2012-10
• Device Lot Number: PFT3910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Date Manufacturer Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1