MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. PRUITT AORTIC OCCLUSION CATHETER

Catalog Number 2100-12

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

We have received the complaint device for evaluation and we have confirmed the reported incident.When we attempted to inflate the balloon with saline, we observed a leakage at the joint of the inflation arm and the irrigation lumen.The root cause of the issue was determined to be a manufacturing operator error- not enough glue was applied on the joint during assembly process.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.Therefore, we believe that it was an isolated incident.The malfunction was detected by the user during pre-use check.Device was not used in the patient.Procedure was completed using another pruitt aortic catheter that they had in stock.

Event Description

During pre-use check, surgeon detected a leakage at the joint where the inflation arm meets the irrigation lumen.Device was not used in the patient.Surgeon completed the procedure using another pruitt aortic occlusion catheter that they had in stock.

• Brand Name: PRUITT AORTIC OCCLUSION CATHETER
• Type of Device: AORTIC OCCLUSION CATHETER
• 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: 8920512
• MDR Text Key: 178781575
• Report Number: 1220948-2019-00106
• Device Sequence Number: 1
• Product Code: DQT
• UDI-Device Identifier: 00840663101511
• UDI-Public: 00840663101511
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K872090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2023
• Device Catalogue Number: 2100-12
• Device Lot Number: PAO1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2018
• 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