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

Model Number	e2012-11
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon had an issue while using a pruitt f3 carotid shunt.At the end of the procedure, the balloon would not deflate, so they had to manually pop the balloon to remove the device.There was no injury reported.
Additional Manufacturer Narrative
The product was returned for evaluation.As reported, the white internal carotid balloon could not be tested as the user had punctured the balloon during use to deflate the balloon.When we inflated the blue common carotid balloon with air, the balloon inflated and deflated properly.However, when we attempted to inflate the common carotid balloon with saline, we experienced strong resistance when we attempted to inflate the balloon.When we attempted to deflate balloon, the balloon did not deflate until the fluid was removed using the attached syringe.No visible damage or abnormalities were observed that would result in the difficulty to inflate/deflate the balloon.The balloon was removed from the shunt and the skive holes were inspected.The distal skive holes were observed to be incomplete resulting in limited flow through the holes.The failure occurred because of an alignment issue when inserting the shunt into the fixture while making the skive holes.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.During manufacturing, 100% in-process inspection is performed for this product to ensure the balloons inflate and deflate properly.Further, we have not received any other complaints of a similar nature for devices from this lot.

• 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
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer Contact: jeffrey oddy ; 63 second ave; burlington, MA 01803 ; 7814251682
• MDR Report Key: 15806115
• Report Number: 1220948-2022-00118
• Device Sequence Number: 5622919
• Product Code: MJN
• UDI-Device Identifier: 00840663101290
• UDI-Public: (01)00840663101290
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/16/2022

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 Model Number: e2012-11
• Device Catalogue Number: E2012-11
• Device Lot Number: QPF1130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Unknown