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

Catalog Number	2012-10
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation for a carotid endarterectomy procedure, the pruitt f3 shunt safety balloon inflated prior to the internal carotid balloon.The surgeon was not comfortable proceeding and elected to use a different device.The issue was identified during preparation, prior to use.No patient injury was reported.
Additional Manufacturer Narrative
The returned product was received for investigation.During testing, it was observed that the safety balloon inflated before the occlusion balloon, even when inflation was performed slowly.The reported event was confirmed; however, the exact root cause could not be determined.It is possible that if the balloons are inflated too rapidly or overinflated, the safety balloon may activate.Repeated or excessive inflation of the safety balloon may also cause stretching, resulting in reduced resistance and preventing the internal carotid balloon from inflating properly.The safety balloon is designed to activate when excess pressure is applied to the internal carotid balloon, reducing the risk of vessel injury due to overinflation.As instructed in the ifu, the balloon should be inflated slowly to avoid premature safety balloon activation, and the safety sleeve should be positioned over the safety balloon once the balloon is in place.Upon completion of balloon inflation, the ifu instructs the user to close the white stopcock and slide the movable sleeve over the safety balloon to prevent reflux from the internal carotid balloon into the safety balloon, thereby maintaining vessel occlusion.A lot history review was conducted with no issues identified in manufacturing or packaging that could be related to this event.All quality control tests met specifications, and no other complaints of a similar nature have been reported for this lot.

• 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: 23024570
• Report Number: 1220948-2025-00159
• Device Sequence Number: 15831287
• Product Code: MJN
• UDI-Device Identifier: 00840663101214
• UDI-Public: (01)00840663101214(11)230925(17)280828(10)XPF1143(91)2012-10
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/11/2025

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 Catalogue Number: 2012-10
• Device Lot Number: XPF1143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2023
• 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