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

Catalog Number	2013-10
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used product related to this event was received for evaluation.Inspection of the device found that the safety balloon was folded over itself.When slowly inflating the balloons the internal carotid balloon was able to be successfully inflated.When quickly inflating the balloon the safety balloon did inflate as reported.It is possible that the pressure applied to inflate the balloon was too much pressure and resulted in the safety balloon activating.As stated in the ifu: "an external safety balloon located on the inflation arm leading to the distal (internal carotid) balloon acts as a mechanism to relieve pressure on the internal l carotid balloon in the event it inflates above optimal size and pressure." additionally, the ifu instructs to slowly inflate the balloon.An unused sample from this lot was tested.No issues were observed.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.No units were rejected during balloon inflation test or leak testing.Note: this is report 1 of 3 related to the first shunt used in the event.Report 1220948-2023-00134 and 1220948-2023-00135 were submitted for the second and third device that was tested during the event, but was not used on the patient.
Event or Problem Description
It was reported the while balloon will not inflate with the safety balloon deployed during a carotid endartarectomy procedure.When the safety balloon was squeezed the white balloon would inflate slightly, but then deflate again.It felt like a latex free balloon.No injury reported to patient.They tested two other devices from the same lot that had the same issue, but they were not used on the patient.Note: this is report 1 of 3 related to the first shunt used in the event.Report 1220948-2023-00134 and 1220948-2023-00135 were submitted for the second and third device that was tested during the event, but was not used on 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 ; 7814251683
• MDR Report Key: 17624239
• Report Number: 1220948-2023-00133
• Device Sequence Number: 14973455
• Product Code: MJN
• UDI-Device Identifier: 00840663101252
• UDI-Public: (01)00840663101252
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/25/2023

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 Catalogue Number: 2013-10
• Device Lot Number: XPF1014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2022
• 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