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

Catalog Number 2105-15

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 11/14/2014

Event Type  malfunction  

Manufacturer Narrative

We have received the complaint device for evaluation and we have confirmed the reported incident.We found that the tyvek lid was already separated on three sides of the tray in which the catheter was contained.Since we observed uniform seal marks on the entire border of the tray, we could confirm that this device was properly sealed during manufacturing.However, at some stage, the tyvek lid was physically removed.We could not confirm if the tyvek lid was removed at the user facility or at some other locations.However, the defect is clearly visible and cannot go undetected.All manufacturing and qc steps were completed in accordance to manufacturing instructions.Further, we have not received any other complaints of a similar nature for devices from this lot.This device did not come in contact with patient and was not used for the procedure.

Event Description

User received an unsealed tray of a lemaitre perfusion catheter.She observed the tyvek lid was already separated at three sides of the tray when it was removed from its outer package.This device did not come in contact with patient and was not used for the procedure.

• Brand Name: LEMAITRE DISTAL PERFUSION CATHETER
• Type of Device: DISTAL PERFUSION 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: 9469474
• MDR Text Key: 179297758
• Report Number: 1220948-2019-00165
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00840663101610
• UDI-Public: 00840663101610
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/13/2019

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: 10/28/2022
• Device Catalogue Number: 2105-15
• Device Lot Number: DPC1109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2017
• 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