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

Catalog Number	2013-10M
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the stopcock of the device was unable to be closed.However, after the product was received and inspection on 26 march 2024, it was found that the device leaked at the stopcock joint which prevented the balloon from properly staying inflated.We are unable to determine if the issue was due to a manufacturing error or resulting from improper handling of the device.It is possible the balloon was deformed as a result of over-inflation or inflating the balloon too rapidly.As the ifu states: slowly inflate the blue common carotid artery balloon with up to 1.5 ml of sterile saline.Do not inflate the internal carotid balloon to any greater volume than is necessary to obstruct blood flow for the internal carotid artery.We have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue.All qc tests passed their requirements.
Event or Problem Description
Based on the initial information, it was reported that the stopcock of the device was unable to be closed.However, after the product was received and inspection on (b)(6) 2024, it was found that the device leaked at the stopcock joint which prevented the balloon from properly staying inflated.As a result, this incident was reassessed to be a reportable event.
Additional Manufacturer Narrative
It was reported that the stopcock of the device was unable to be closed.However, after the product was received and inspected, it was found that the device leaked at the stopcock joint which prevented the balloon from properly staying inflated.Previous investigation into this issue has confirmed the root cause of the malfunction to be a manufacturing operator error, not enough glue was applied on the stopcock joint during the assembly process.Due to reports of similar issues, the product design is being reviewed through dhf0155 to address this issue.The lot history record for the product 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.
Event or Problem Description
Based on the initial information, it was reported that the stopcock of the device was unable to be closed.However, after the product was received and inspection on 26 march 2024, it was found that the device leaked at the stopcock joint which prevented the balloon from properly staying inflated.As a result, this incident was reassessed to be a reportable event.Note: sending follow up due to incorrect information was accidentally entered in section h11.The write up contained data from another claim.

• 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: 18982812
• Report Number: 1220948-2024-00081
• Device Sequence Number: 20890988
• Product Code: MJN
• UDI-Device Identifier: 00840663101252
• UDI-Public: (01)00840663101252
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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 Expiration Date: 08/28/2007
• Device Catalogue Number: 2013-10M
• Device Lot Number: PFT1016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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