MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. LEMAITRE OVER-THE-WIRE EMBOLECTOMY CATHETER

Model Number 1651-38

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/03/2020

Event Type  malfunction  

Manufacturer Narrative

We have received the complaint device for investigation.We observed that the tyvek lid has completely separated from the tray.We observed complete heat seal marks on the tyvek lid suggesting that the tyvek lid was properly bonded to the tray during the sealing process.We observed that the product label opposite to the tyvek lid was moist suggesting that it might have come in contact with liquid for an extended period.We have also received additional 13 units of 3f over-the-wire embolectomy catheters (same lot#) from the distributor that was previously shipped to them along with this complaint unit.We observed in 9 packaging tubes, the sterility was compromised since a portion of the tyvek lid has unsealed from the tray.In all of the returned units, we observed the packaging labels were moist.Based on our investigation, it is likely that these devices were exposed to adverse conditions that allow them to get wet, such as rain on a loading dock or flooding during shipping the devices to the distributor.We do perform 100% inspection of the packaging tubes after sterilization to ensure a complete seal.We also perform a burst test on a sample of units each day on the manufacturing floor to ensure the sealing is not compromised.Recently, we have also tested 30 units of these packages per ista standards.We exposed these units to high temperature and humidity levels prescribed in the standard.We then conducted a peel test of the tyvek lids on all of those units to ensure the seal was not compromised.All of the 30 units passed the requirement.Based on this test, we can conclude that the packaging can withstand temperature and humidity fluctuations during shipping.We have manufactured (b)(4) units of over-the-wire embolectomy catheter with lot# otw4606.Out of these (b)(4) were shipped to the distributor in (b)(4).The remaining (b)(4) units have been sold to other geographies.We have only received complaints from the customers who received the catheters from the (b)(4) distributor.We have not received any other complaints from other geographies.These complaints represent the first of their kind and based on the nature of the defect and the condition of the product, this information suggests a localized issue with this distributor.We have requested additional information from the distributor.The investigation is ongoing.Please note that we have also reported manufacturer's incident report# 1220948-2021-00053 related to another similar incident that was reported to us by the same distributor.Both of the complaint devices were shipped together to the distributor on (b)(6) 2020.

Event Description

Upon receiving a complaint related to over-the-wire embolectomy catheter's tyvek lid not being properly sealed (manufacturer's incident report# 1220948-2021-00053), the distributor reached out to another hospital to whom they had sold the over-the-wire embolectomy catheters from the same complaint lot#.The customer confirmed that 1 out of 5 units has a similar issue as well.This is report 2 of 2.

• Brand Name: LEMAITRE OVER-THE-WIRE EMBOLECTOMY CATHETER
• Type of Device: EMBOLECTOMY 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 ; 7212212266
• MDR Report Key: 11925073
• MDR Text Key: 264578671
• Report Number: 1220948-2021-00054
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00840663100668
• UDI-Public: 00840663100668
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K022145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/02/2021

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 Model Number: 1651-38
• Device Catalogue Number: 1651-38
• Device Lot Number: OTW4606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Manufacturer Received: 05/03/2021
• Initial Date FDA Received: 06/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2020
• 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