BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER

    MDR report key: 18183209 · Received November 21, 2023

    Report

    Report Number
    1220948-2023-00198
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Date of Event
    October 25, 2023
    Report Date
    November 21, 2023
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    DXE
    UDI-DI
    00840663100743
    PMA / PMN Number
    K022145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR INVESTIGATION. THE REPORTED PROBLEM WAS CONFIRMED. THE BALLOON WAS FOUND RUPTURED. DUE TO THE NATURE OF THE PRODUCT, BALLOON RUPTURES ARE AN EXPECTED RISK WHEN USING THIS PRODUCT. AS STATED IN THE IFU: AS WITH ALL CATHETERIZATION PROCEDURES, COMPLICATIONS MAY OCCUR. THESE MAY INCLUDE BUT ARE NOT LIMITED TO: INFECTION, LOCAL HEMATOMAS, INTIMAL DISRUPTION, ARTERIAL DISSECTION, PERFORATION AND RUPTURE, HEMORRHAGE, ARTERIAL THROMBOSIS, DISTAL EMBOLI OF BLOOD CLOTS OR ARTERIOSCLEROTIC PLAQUE, AIR EMBOLUS, ANEURYSMS, ARTERIAL SPASMS, ARTERIOVENOUS FISTULA FORMATION, BALLOON RUPTURE OR TIP SEPARATION WITH FRAGMENTATION AND DISTAL EMBOLIZATION. THE POSSIBILITY OF BALLOON RUPTURE MUST BE TAKEN INTO ACCOUNT WHEN CONSIDERING THE RISKS INVOLVED IN THE CATHERIZATION PROCEDURE. THE LOT NUMBER OF THE PRODUCT WAS NOT PROVIDED. THEREFORE, WE'RE UNABLE TO PERFORM A LOT REVIEW. CAPA 2021-009 WAS PREVIOUSLY OPENED TO ADDRESS THIS ISSUE. NO FURTHER ACTION NEEDED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BALLOON RUPTURED DURING AN EMBOLECTOMY PROCEDURE. THE OPERATION WAS COMPLETED SUCCESSFULLY USING ANOTHER CATHETER. NO INJURY WAS REPORTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2000903 TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER EMBOLECTOMY CATHETER DXE LEMAITRE VASCULAR, INC. UNKNOWN 00840663100743

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown