BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 1051065 · Received May 22, 2008

    Report

    Report Number
    3004742232-2008-00006
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 15, 2008
    Report Date
    April 15, 2008
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCW
    PMA / PMN Number
    K071427
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: DEVICE ANALYSIS CONFIRMED THE REPORTED COMPLAINT. THE GUIDE WIRE REMAINED INSIDE OF THE OAD WHEN RECEIVED. THE GUIDE WIRE SPRING TIP REMAINED INTACT AND NO KINKS OR SEVERE BENDS WERE NOTED. TISSUE WAS PRESENT BOTH PROXIMAL AND DISTAL TO THE CROWN ON THE DRIVE SHAFT. IN ADDITION, TISSUE WAS FOUND LODGED BETWEEN THE SALINE SHEATH AND THE DRIVE SHAFT JUST INSIDE OF THE DISTAL END OF THE SALINE SHEATH. A SMALL AMOUNT OF TISSUE WAS ALSO PRESENT BETWEEN THE DISTAL TIP BUSHING OF THE OAD AND THE GUIDE WIRE. ONCE THIS TISSUE WAS REMOVED WITH GENTLE TRACTION, THE OAD WAS SUCCESSFULLY REMOVED FROM THE GUIDE WIRE WITHOUT RESISTANCE. THE DEVICE HISTORY RECORD FOR THIS LOT NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE DEVICE METS ITS MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS. THE ROOT CAUSE OF THE REPORTED EVENT WAS TISSUE WRAPPED AROUND THE DRIVE SHAFT CAUSING THE DEVICE TO SLOW DOWN AND BIND TO THE GUIDE WIRE PREVENTING ITS REMOVAL.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM MCW CARDIOVASCULAR SYSTEMS, INC. DB-70-150L 13316

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention BARD FLUENCY COVERED STENT| EV3 INVATEC AMPHERION BALLOON DILATION CATHETER