BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENDIT21 MICROCATHETER

    MDR report key: 18182213 · Received November 21, 2023

    Report

    Report Number
    3017278832-2023-00002
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Date of Event
    May 5, 2023
    Report Date
    June 2, 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

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO FINDINGS RELATED TO MANUFACTURING. 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

    PATIENT WITH A GIANT CAVERNOUS SINUS ANEURYSM. RADIAL ACCESS WITH THE BENDIT21 MICROCATHETER WAS EMPLOYED TO REACH THE ANEURYSM. DURING THE ACCESS ATTEMPT, THE CATHETER BROKE AND WHILE REMOVING A DISTAL SECTION OF THE CATHETER REMAINED WITHIN THE FOREARM AND WAS REMOVED USING A SNARE. THE BENDIT21 MICROCATHETER IS INTENDED FOR FEMORAL ACCESS, THE RISK PROFILE OF USING THE DEVICE IN RADIAL ACCESS IS NOT KNOWN. THE PHYSICIAN TRANSFERRED TO FEMORAL ACCESS AND USED A SECOND BENDIT21 CATHETER WHICH SUCCEEDED TO OBTAIN ACCESS TO THE ANEURYSM AND ENABLE FURTHER TREATMENT OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1992451 BENDIT21 MICROCATHETER BENDIT21 MICROCATHETER QJP BEND IT TECHNOLOGIES LTD. BDT21157U2 230101 17290018072049

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female