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 05/12/2019

Event Type  malfunction  

Manufacturer Narrative

We have received the complaint device for evaluation.However, we were unable to replicate the reported incident.When we attempted to deflate the balloon of the distal perfusion catheter after inflating it with saline to a recommended volume of 3.4 ml, we were able to properly deflate the balloon.We attempted to recreate the defect multiple times by inflating the balloon with different volumes of saline.However, we were unable to replicate the reported defect as the balloon deflated properly each time.Hence, we could not determine the cause of the failure as the device worked properly during our evaluation 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.This issue was detected during pre-use check.So, the patient was not exposed to this catheter.Procedure was completed using another distal perfusion catheter.

Event Description

During pre-use check, after surgeon inflated the balloon of the distal perfusion catheter with saline, he experienced difficulty deflating the balloon.It either deflated only partially or took longer time to deflate completely.This malfunction was detected during pre-use check.So, the patient was not exposed to this catheter.

• 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: 8713437
• MDR Text Key: 151275159
• Report Number: 1220948-2019-00071
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00840663101610
• UDI-Public: 00840663101610
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Catalogue Number: 2105-15
• Device Lot Number: DPC1111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2018
• 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