BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTH 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 3220992 · Received July 11, 2013

    Report

    Report Number
    3004742232-2013-00019
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCW
    PMA / PMN Number
    K110389
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE FACILITY; THEREFORE, AN ANALYSIS OF THE ACTUAL COMPLAINT DEVICE IS NOT POSSIBLE. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. THE ROOT CAUSE FOR THE REPORTED EVENT IS UNKNOWN. (B)(4). DEVICE DISCARDED BY FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORBITAL ATHERECTOMY (OA) TREATMENT PROCEDURE, THE TIP OF THE VIPERWIRE HAD FRACTURED OFF REQUIRING SURGICAL INTERVENTION. THE PHYSICIAN USED A 2.0 CLASSIC CROWN FOR AN INTERVENTION IN THE SFA/CFA. WHEN THE TREATMENT WAS COMPLETED, THE PHYSICIAN REMOVED THE OAD AND THE VIPERWIRE. AT THIS TIME HE NOTED THAT THE TIP OF THE VIPERWIRE HAD FRACTURED OFF AND REMAINED IN THE PATIENT'S BODY. THE PATIENT WAS TAKEN TO SURGERY FOR FURTHER INTERVENTION. THE FACILITY DISCARDED BOTH THE OAD AND THE VIPERWIRE. THREE WRITTEN REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE OF THE PHYSICIAN, BUT NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320933 STEALTH 360 ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE MCW CARDIOVASCULAR SYSTEMS INCORPORATED VPR-GW-14

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention