MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. LEMAITRE DISTAL PERFUSION CATHETER; CARDIOPULMONARY BYPASS VASCULAR CATHETER

Catalog Number 2105-15

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/23/2019

Event Type  malfunction  

Manufacturer Narrative

We have not received the complaint device for evaluation.However, we have confirmed the reported incident based on the picture of the balloon provided to us by the hospital.The balloon inflated on only side of the lumen.Our manufacturing team does conduct 100% inspection on each device and test them for balloon functionality.Each of the balloons are inflated with air using a syringe and then inspected to ensure balloons inflate concentric.At this time, we could not conclusively determine the root cause of the defect.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.In fact, this is the first and only complaint we have received of this nature in the lifetime of this device.We have not seen any adverse or upward trend relating to this attribute.Hence, no corrective action is required at this time.

Event Description

During pre-use check, the balloon of the distal perfusion catheter inflated non-concentric.

• Brand Name: LEMAITRE DISTAL PERFUSION CATHETER
• Type of Device: CARDIOPULMONARY BYPASS VASCULAR CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 02148
• 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: 8488700
• MDR Text Key: 142769490
• Report Number: 1220948-2019-00038
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00840663101610
• UDI-Public: 00840663101610
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K032041
• 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: 04/05/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2023
• Device Catalogue Number: 2105-15
• Device Lot Number: DPC1115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2019
• Initial Date FDA Received: 04/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2018
• 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