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

Catalog Number 2105-15

Device Problem Deflation Problem (1149)

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

Event Date 11/22/2018

Event Type  malfunction  

Manufacturer Narrative

We have received both devices for evaluation.However, we were unable to confirm the reported defect with both devices.When the balloons in both devices were inflated to their maximum recommended volume of 3.4 ml, both balloons deflated normally by pulling the plunger of the syringe.All of the measurements in both devices were found to be within specification.Balloons in both catheters inflated symmetrically.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.Hence, we consider this to be an isolated incident.The procedure was completed using another distal perfusion catheter that they had in stock.

Event Description

During pre-use check, balloons of the two distal perfusion catheters (catalog # 2105-15, lot# dpc1115) failed to deflate completely.

• 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: 8204475
• MDR Text Key: 132387487
• Report Number: 1220948-2018-00114
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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