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

Catalog Number	E2012-10
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded and not returned for evaluation.Therefore, the exact root cause of the balloon rupture could not be determined.As stated in the ifu: exercise caution when encountering extremely diseased vessels.Arterial rupture or balloon failure due to sharp calcified plaque may occur.The possibility of balloon rupture must be taken into account when considering the risks involved in the endarterectomy procedure.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.Note: this is report 1 of 2 related to the first event/device.Report 1220948-2024-00211 was submitted for the second device/event.
Event or Problem Description
It was reported that the pruitt f3 carotid shunt balloon ruptured during a carotid endarterectomy procedure.The issue was detected due to the balloon leaking and was clamped to address it.No injury was reported to the patient.Note: this is report 1 of 2 related to the first event/device.Report 1220948-2024-00211 was submitted for the second device/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: peter song ; 63 second ave; burlington, MA 01803 ; 7814251683
• MDR Report Key: 20481709
• Report Number: 1220948-2024-00205
• Device Sequence Number: 12863428
• Product Code: MJN
• UDI-Device Identifier: 00840663101283
• UDI-Public: (01)00840663101283(11)240624(17)290528(10)XPF00001235(91)E2012-10
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/18/2024

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: E2012-10
• Device Lot Number: XPF00001235
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2024
• 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