BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENDIT21 MICROCATHETER

    MDR report key: 18178687 · Received November 20, 2023

    Report

    Report Number
    3017278832-2023-00001
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    May 4, 2023
    Report Date
    February 6, 2023
    Manufacturer
    BEND IT TECHNOLOGIES LTD.
    Product Code
    QJP
    UDI-DI
    17290018072049
    PMA / PMN Number
    K203842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BENDIT BELIEVED IT HAD SUCCESSFULLY INITIATED A WEB TRADER ACCOUNT AND COMPLETED SUBMITTING ALL REQUISITE TEST DATA PRIOR TO TIMELY FILING THIS 3500A. UNFORTUNATELY, THE COMPANY RECENTLY RECOGNIZED THAT THIS WAS NOT THE CASE. AS A RESULT, THIS EVENT IS BEING FILED RETROSPECTIVELY.

    Description of Event or Problem · 0

    THE BENDIT21 MICROCATHETER WAS USED TO ACCESS THE ACA ANEURYSM ANEURYSM IN PATIENT WITH HIGHLY TORTUOUS BLOOD VESSEL ANATOMY. DUE TO THE EXTREMELY HIGH TORTUOSITY A SIGNIFICANT ARTICULATION AND TORQUING FORCES WERE APPLIED TO THE CATHETER RESULTING IN CATHETER BREAKAGE. CATHETER WAS REMOVED WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2088556 BENDIT21 MICROCATHETER BENDIT21 MICROCATHETER QJP BEND IT TECHNOLOGIES LTD. BDT21157U2 230101 17290018072049

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female