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

Model Number	2013-10
Medical Device Problem Codes	Material Rupture (1546); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Ischemia (1942)
Date of Event	12/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not received for evaluation.Therefore, the root cause could not be established.The device becoming dislodged from its intended position during use is a result of either balloon damage or the device not being secured properly.The dislodgement of the device resulted in bleeding during the procedure and required an alternate shunt to be used to complete the procedure.The ifu provides the following warning related to the possibility of balloon issues during use: 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.Additionally, we have not received any reports of similar issues occurring for this lot.
Event or Problem Description
During the use of a pruitt f3 carotid shunt, a few minutes after inserting the device, the end inserted into the aa common carotid artery slipped off.This indicated that the balloon had ruptured.The shunt had to be removed and replaced, which resulted in bleeding and increasing of the cerebral ischemia time.

• 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: 16248702
• Report Number: 1220948-2023-00007
• Device Sequence Number: 6453809
• Product Code: MJN
• UDI-Device Identifier: 00840663101252
• UDI-Public: (01)00840663101252
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2013-10
• Device Catalogue Number: 2013-10
• Device Lot Number: QPF1151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2022
• Initial Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown