MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC TUFTEX 4F OVER-THE-WIRE EMBOLECTOMY CATHETER

Model Number	1651-44
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the complaint device for evaluation and we have confirmed the reported incident.We observed a circumferential balloon rupture.We were able to properly flush the irrigation lumen and inflation lumen.We did not observe any stretching of the catheter lumen.During our follow-up, we were informed that the catheter was operated at the stenotic region of the vessel.As stated in the ifu, 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.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 from this lot number.There was no harm to the patient because of this balloon malfunction.The surgeon used another tuftex over-the-wire embolectomy catheter to complete the procedure.
Event or Problem Description
The balloon of the tuftex over-the-wire embolectomy catheter ruptured during an embolectomy procedure.Surgeon then used another tuftex over-the-wire embolectomy catheter to complete the procedure.There was no harm to the patient because of this incident.

• Brand Name: TUFTEX 4F 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: 12897253
• Report Number: 1220948-2021-00105
• Device Sequence Number: 17118592
• Product Code: DXE
• UDI-Device Identifier: 00840663100675
• UDI-Public: 00840663100675
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2021

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: 1651-44
• Device Catalogue Number: 1651-44
• Device Lot Number: OTW4784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2021
• 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