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

Catalog Number	2013-10
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for investigation.The reported problem was confirmed.The safety balloon was observed to be leaking.It is possible to damage the safety balloon if the user mishandled the device when removing the safety sleeve or if the sleeve was incorrectly moved in the direction of the stopcock instead of toward the infusion area of the internal carotid lumen.As stated in the ifu: the sheath should be moved and hang loosely on the infusion area of the distal lumen (away from the stopcock area).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.Additionally, we have not received any reports of similar issues occurring for this lot.
Event or Problem Description
It was reported that the pruitt f3 safety balloon leaked at the yellow part of the white tap line while priming for a case.Device was unable to be used.No injury was reported to the patient.

• 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 ; 9784251683
• MDR Report Key: 20260433
• Report Number: 1220948-2024-00180
• Device Sequence Number: 7564219
• Product Code: MJN
• UDI-Device Identifier: 00840663101252
• UDI-Public: (01)00840663101252(11)230609(17)280528(10)XPF1111(91)2013-10
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2024

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 Catalogue Number: 2013-10
• Device Lot Number: XPF1111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2023
• 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