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

Model Number	e2012-11
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported pruitt f3 carotid shunt tube has hole in it.The issue was found during pre-use check and no injury occurred.
Additional Manufacturer Narrative
The device was received for evaluation and the reported issue was confirmed.A hole was observed in the safety balloon of the device which allowed fluid to leak when attempting to inflate the internal carotid balloon.The damage likely occurred while removing the protective balloon sleeve prior to use.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.

• 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: jeffrey oddy ; 63 second ave; burlington, MA 01803 ; 7814251682
• MDR Report Key: 16513554
• Report Number: 1220948-2023-00024
• Device Sequence Number: 15055628
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2023

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: XPF0068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• 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