BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DVI SCA-EX

    MDR report key: 17363 · Received September 21, 1994

    Report

    Report Number
    17363
    Event Type
    Malfunction
    Date Received
    September 21, 1994
    Date of Event
    September 12, 1994
    Report Date
    September 20, 1994
    Manufacturer
    DEVICES FOR VASCULAR INTERVENTION
    Product Code
    MCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING USE OF PRODUCT, CUTTER BECAME DISENGAGED FROM CATHETER AND WOULD NOT ALLOW CUTTER TO MOVE FORWARD AND BACKWARD. NO ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DVI SCA-EX CUTTING DEVICE MCX DEVICES FOR VASCULAR INTERVENTION EX-70-09 141992

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other