BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVERHAWK POWERCROSS

    MDR report key: 3652616 · Received February 5, 2014

    Report

    Report Number
    3652616
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    January 24, 2014
    Report Date
    February 5, 2014
    Manufacturer
    EV3 ENDOVASCULAR
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    PERIPHERAL ENDOVASCULAR INTERVENTIONAL THERAPY PROCEDURE FOR CLAUDICATION PERFORMED. COVIDIEN PRODUCT SILVERHAWK ATHERECTOMY DEVICE LX-M, LOT # 9655314 WAS USED. THE THUMB SWITCH ON THE BATTERY PACK DEVICE WAS JAMMING DURING USE. NO PATIENT HARM. ANOTHER DEVICE OBTAINED.====================== MANUFACTURER RESPONSE FOR SILVERHAWK ATHERECTOMY DEVICE, POWERCROSS PTA BALLOON, SILVERHAWK LX-M, POWERCROSS 6X200MMPTA BALLOON (PER SITE REPORTER).====================== MORE THAN WILLING TO EVALUATE AND CORRECT THE ISSUE IF NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74583 SILVERHAWK POWERCROSS CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3 ENDOVASCULAR LX-M 9655314

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR NO OTHER THERAPIES