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

Model Number	2012-12
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation.However, we were unable to confirm the reported incident during our investigation process.When we attempted to inflate the internal carotid balloon with saline, we were unable to inflate the balloon.We observed a hole in the internal carotid balloon.As a result, the balloon could not inflate.The common carotid balloon inflated and deflated properly.Based on our device evaluation, it is likely that this device came in contact with a sharp object during the pre-use check that damaged the balloon.Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.Further, we have not received any other complaints of a similar nature for devices from this lot.
Event or Problem Description
One of the balloons of the pruitt f3 carotid shunt failed to deflate properly.User did not provide any additional information.

• 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: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 13060052
• Report Number: 1220948-2021-00118
• Device Sequence Number: 13809792
• Product Code: MJN
• UDI-Device Identifier: 00840663101238
• UDI-Public: 00840663101238
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K051067
• 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
• Report Date (Section B): 12/21/2021

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: 12/28/2024
• Device Model Number: 2012-12
• Device Catalogue Number: 2012-12
• Device Lot Number: PFT3765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2021
• Initial Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2020
• 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