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

Catalog Number 2012-10M

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2023

Event Type  malfunction  

Event Description

It was reported the balloon for the internal carotid artery (icb) did not inflate well.The safety balloon inflated greatly instead of icb.The operation was successfully completed using another pft.No injury was reported to the patient.

Manufacturer Narrative

The device was not returned for evaluation.The provided picture from lemaitre japan appears to show the safety balloon inflated instead of the internal carotid balloon.While the reported event was confirmed, the exact root cause of the reported issue could not be determined.The safety balloon is intended to inflate when excess pressure is applied to the internal carotid balloon to reduce the possibility of injury by over-inflation.It is possible the balloon was over inflated or inflated too rapidly and resulted in the safety balloon inflating instead of the internal carotid balloon.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.

• Brand Name: PRUITT F3 CAROTID SHUNT
• Type of Device: 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: 18315826
• MDR Text Key: 330355214
• Report Number: 1220948-2023-00204
• Device Sequence Number: 1
• Product Code: MJN
• UDI-Device Identifier: 00840663101214
• UDI-Public: (01)00840663101214
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K182916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2012-10M
• Device Lot Number: MPF1022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1