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

Model Number	1651-78
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
3 units were received with the packaging wet.The site suspected the product to no longer be sterile and therefore was not usable in the operating room.The product was not released to the or from the hospital stock.There was no patient involvement.This is report 2 of 3.
Additional Manufacturer Narrative
We have not received the complaint devices for evaluation.Hence, we could not conclusively determine the root cause of the incident.The instructions for use indicate that the device is supplied in a sterile package and that sterility is assured as long as packages are unopened and/or undamaged.Therefore, the device sterility may be compromised if the packages are opened or damaged as a result of becoming wet.This issue was found pre-use and there was no patient involvement.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 from other customers of a similar nature for devices from this lot.Please note that we have also submitted manufacturer incident report number 1220948-2022-00085 and 1220948-2022-00087 relating to two other tuftex over-the-wire embolectomy catheters that were involved in this event.

• Brand Name: TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER
• Common Device Name: 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 ; 7812212266
• MDR Report Key: 15304748
• Report Number: 1220948-2022-00086
• Device Sequence Number: 5287329
• Product Code: DXE
• UDI-Device Identifier: 00840663100736
• UDI-Public: 00840663100736
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K022145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 08/26/2022

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
• Operator of Device: Health Professional
• Device Model Number: 1651-78
• Device Catalogue Number: 1651-78
• Device Lot Number: QOT1199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown