MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. TUFTEX EMBOLECTOMY CATHETER

Model Number	1601-58
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not received the catheter for investigation since it was discarded by the user.Hence, we could not conclusively determine the root cause of the reported incident.During our follow-up investigation, we were informed by the surgeon that the balloon was used to remove a thromboembolism.The catheter was used in a non-calcified vessel as it was used to remove a clot due to an acute ischemia.The catheter ruptured during a trans-popliteal retrograde thrombectomy.The balloon of the tuftex embolectomy catheter ruptured during the forth pass.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.There was no harm to the patient because of this malfunction.
Event or Problem Description
During a thrombectomy procedure, the balloon of the tuftex embolectomy catheter ruptured when the surgeon attempted to remove the thrombus from the patient's vessel.The balloon ruptured in his 4th pass.The surgeon failed his first three attempts to remove the thrombus from the patient's vessel.There was no harm to the patient because of this malfunction.

• Brand Name: TUFTEX EMBOLECTOMY CATHETER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; lemaitre vascular, inc.; 63 second ave 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: 14466011
• Report Number: 1220948-2022-00041
• Device Sequence Number: 4637670
• Product Code: DXE
• UDI-Device Identifier: 00840663100514
• UDI-Public: 00840663100514
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K992368
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2022

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: 1601-58
• Device Catalogue Number: 1601-58
• Device Lot Number: QSL1026
• 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: 04/21/2022
• Initial Report FDA Received Date: 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown