BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 2212692 · Received August 11, 2011

    Report

    Report Number
    3004742232-2011-00020
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    CARDIOVASCULAR SYSTEMS INC.
    Product Code
    MCW
    PMA / PMN Number
    K071427
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORBITAL ATHERECTOMY (OA) TREATMENT PROCEDURE, THE VIPERWIRE FRACTURED INSIDE OF THE PATIENT AND WAS NOT RETRIEVED. A VESSEL PERFORATION OCCURRED. THE LESION BEING TREATED WAS HEAVILY CALCIFIED, 90% STENOTIC, AND LOCATED IN THE DISTAL PT ARTERY. THE PHYSICIAN USED A 6F INTRODUCER SHEATH TO ACCESS THE TARGET LESION FROM AN ANTEGRADE APPROACH. HE PERFORMED TWO RUNS AT LOW SPEED AND THEN PULLED THE DEVICE BACK TO TAKE A PICTURE WITH CONTRAST. AT THIS TIME HE NOTICED THAT PART OF THE DISTAL TIP OF THE VIPERWIRE HAD BROKEN OFF AND A VESSEL PERFORATION HAD OCCURRED. HE APPLIED PRESSURE TO THE VESSEL AND REQUESTED A SURGICAL CONSULT. THE SURGEON RECOMMENDED THAT THE FRACTURED TIP SHOULD NOT BE REMOVED. FURTHER INTERVENTION WAS ABORTED. THE PATIENT REMAINED STABLE THROUGHOUT AND FOLLOWING THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM MCW CARDIOVASCULAR SYSTEMS INC. VPR-GW-14

    Patients

    Seq Age Sex Outcome Treatment
    1 Other