BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 2003824 · Received February 24, 2011

    Report

    Report Number
    3004742232-2011-00004
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 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
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORBITAL ATHERECTOMY (OA) TREATMENT PROCEDURE, A VESSEL DISSECTION OCCURRED AND REQUIRED THE PLACEMENT OF A STENT. THE LESION BEING TREATED WAS A DIFFUSE, 100% STENOTIC CTO, 30-35CM IN LENGTH AND LOCATED THROUGHOUT THE SFA. THE VESSEL WAS MILDLY TORTUOUS WITH A 5 MM REFERENCE VESSEL DIAMETER. THE PHYSICIAN USED A 6 FR (6X45) INTRODUCER SHEATH AND AN ANTEGRADE CROSSOVER APPROACH FROM RIGHT TO LEFT TO ACCESS THE TARGET LESION. THE DEVICE WAS RUN AT LOW SPEED FOR 2 PASSES, AND THEN AT MEDIUM SPEED FOR 2 PASSES, AND THEN AT HIGH SPEED FOR 2 PASSES IN EACH REGION OF THE CTO. RUN TIMES WERE CONSISTENTLY FROM 20-30 SECONDS EACH. THE TOTAL EVENT TIME WAS JUST OVER 4 MINS AND AT THE END OF THE FINAL RUN AS THE CROWN WAS APPROACHING THE ADDUCTOR CANAL REGION, A LOUD, HIGH-PITCHED NOISE WAS HEARD. THE PHYSICIAN WAS UNABLE TO MOVE THE CROWN AT THIS POINT. THE SHAFT OF THE DEVICE HAD BROKEN AT AN AREA OUTSIDE OF THE PATIENT'S BODY CLOSE TO THE HANDLE. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, A PORTION OF THE DRIVESHAFT INCLUDING THE CROWN AND A PORTION OF THE VIPERWIRE REMAINED IN THE VESSEL. WHEN THE VIPERWIRE WAS REMOVED, THE REST OF THE DRIVESHAFT AND CROWN WERE REMOVED AS A UNIT WITH IT. NO PORTION OF THE DEVICE REMAINED IN THE PATIENT'S BODY. THE ATHERECTOMY PORTION OF THE PROCEDURE HAD BEEN SUCCESSFULLY COMPLETED AT THIS POINT. THERE WERE TWO DISSECTIONS IN THE VESSEL DURING THIS INTERVENTION, BUT NO PERFORATION AND NO HEMORRHAGE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANGIOPLASTY (USING A 5X10 BALLOON) AND STENT PLACEMENT TO REPAIR THE DISSECTIONS. THE PATIENT IS DOING WELL AND HAS SINCE BEEN DISCHARGED TO HOME. 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. DBG-SCT30-175 37703

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 6X45 TERUMO INTRODUCER SHEATH