MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC TUFTEX 5F PLUS OVER-THE-WIRE EMBOLECTOMY CATHETER

Model Number	1651-84
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation.We observed excessive necking of the catheter lumen.As a result, we were unable to inflate the balloon.The total catheter shaft was measured to be 51.7 cm.We did not observe any damage to the balloon.Both of the ligatures were held in place properly.During our in-process inspection, we have also tested a sample of over-the-wire embolectomy catheters from this lot number.The balloons of these catheters were pull tested to their validated parameters.After the test, the balloons and ligatures of these catheters were inspected.All of the balloons inflated properly and deflated within their acceptable time limit.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.Our ifu clearly/ appropriately warns the users about the risks that could occur with the use of the embolectomy catheter including the risk of balloon rupture due to exposure to calcified plaque and overinflated balloon.The arterial embolectomy catheter is not recommended for the removal of fibrous, adherent or calcified material (eg.Chronic clot, atherosclerotic plaque).This catheter is not designed to withstand the additional pull force needed to remove these materials.
Event or Problem Description
The balloon of the tuftex over-the-wire failed to deflate when the surgeon attempted to deflate it inside the patient's vessel.As a result, the balloon ruptured when he attempted to remove the catheter through the introducer.He had made two passes before encountering this issue and both times the balloon deflated properly.There was no harm to the patient because of this incident.

• Brand Name: TUFTEX 5F PLUS 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: 12980499
• Report Number: 1220948-2021-00111
• Device Sequence Number: 4292332
• Product Code: DXE
• UDI-Device Identifier: 00840663100743
• UDI-Public: 00840663100743
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/10/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1651-84
• Device Catalogue Number: 1651-84
• Device Lot Number: QOT1303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2021
• 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