BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPERWIRE ADVANCED

    MDR report key: 6431616 · Received March 24, 2017

    Report

    Report Number
    6431616
    Event Type
    Malfunction
    Date Received
    March 24, 2017
    Date of Event
    November 8, 2016
    Report Date
    March 8, 2017
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER MULTIPLE PASSES WITH THE CARDIOVASCULAR SYSTEMS, INC. (CSI), WE WERE ATTEMPTING TO TAKE OUT THE CSI DEVICE. THE PHYSICIAN REALIZED THE WIRE HAD BROKEN OFF. X-RAYED TO SEE WHERE WIRE WAS AND WAS ABLE TO REMOVE PIECES OF WIRE FROM SHEATH. THE SHEATH WAS THEN REMOVED. WE REMOVED AS MUCH AS WE COULD OF THE WIRE. THE PHYSICIAN X-RAYED AND A PIECE WAS SEEN IN SMALL SIDE BRANCH IN RIGHT FOOT. NO BLOOD FLOW WAS OBSTRUCTED SO THE DR. OPTED TO LEAVE IN PLACE BECAUSE SNARING WOULD BE TOO RISKY. THE WIRE AND BOX WAS SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214457 VIPERWIRE ADVANCED CATHETER, PERIPHERAL, ATHERECTOMY MCW CARDIOVASCULAR SYSTEMS INCORPORATED 165607

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR