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

Catalog Number	2013-10
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pruit f3 carotid shunt balloon ruptured during a carotid endarterectomy.They had to get control with slings around the distal end of the shunt to resolve the issue.No injury was reported to the patient and fully recovered.
Additional Manufacturer Narrative
The device was received for investigation.Inspection of the device found the safety balloon to be ruptured.It is possible that the internal carotid balloon was over inflated or inflated too rapidly resulting in the safety balloon inflating or that the safety balloon was inadvertently damaged during the procedure.The safety sleeve used to cover the safety balloon was not on the safety balloon when the device was returned, however it is unknown if it was in place during use.As stated in the ifu: "attach a 3 ml syringe to the white stopcock and slowly inflate the internal carotid artery balloon with up to 0.25 ml of sterile saline.When the balloon is inflated sufficiently to occlude the artery, back-bleeding around the shunt will stop, there will be a feeling of slight resistance to further inflation and/or there will be a slight distention of the external safety balloon.This is the end-point: stop inflation immediately at this point.The lot history record for the device was reviewed, no issues were found during manufacturing or packaging that would cause or contribute to the reported event.We have not received any similar complaints related to this lot number.

• Brand Name: PRUITT F3 CAROTID SHUNT
• Common Device Name: CAROTID SHUNT
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC; 63 second ave; burlington MA 01803
• Manufacturer Contact: peter song ; 63 second ave; burlington, MA 01803 ; 7814251683
• MDR Report Key: 20310196
• Report Number: 1220948-2024-00176
• Device Sequence Number: 7726756
• Product Code: MJN
• UDI-Device Identifier: 00840663101252
• UDI-Public: (01)00840663101252(11)210929(17)260828(10)QPF1106(91)2010-10
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K182916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/26/2024

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: 08/28/2026
• Device Catalogue Number: 2013-10
• Device Lot Number: QPF1106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female