BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 4110958 · Received September 23, 2014

    Report

    Report Number
    3004742232-2014-00043
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 18, 2014
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCW
    PMA / PMN Number
    K133399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETAINED BY THE FACILITY; THEREFORE, AN ANALYSIS OF THE ACTUAL COMPLAINT DEVICE IS NOT POSSIBLE. THE DEVICE HISTORY RECORD FOR THIS OAD LOT NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE MET MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. (B)(4). DEVICE DISCARDED BY FACILITY.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: CSI WAS ALLOWED TO VISUALLY EXAMINE THE DEVICE AT THE FACILITY, UNDER SUPERVISION OF FACILITY STAFF. VISUAL EXAMINATION REVEALED THAT THE DRIVESHAFT WAS FRACTURED AND DEFORMED 3MM DISTAL TO THE DISTAL EDGE OF THE CROWN, BUT THE CROWN REMAINED INTACT ON THE DRIVESHAFT. WHEN THE CONTROL KNOB WAS ADVANCED FULLY DISTALLY, THE DRIVESHAFT EXHIBITED A SLIGHT WAVE SHAPE. BIOLOGICAL MATERIAL WAS OBSERVED ON THE DISTAL EDGE OF THE CROWN AND AROUND THE FRACTURE LOCATION ON THE DRIVESHAFT. THE GUIDEWIRE WAS NOT IN THE DEVICE AND WAS NOT AVAILABLE FOR EVALUATION. NO CONCLUSIVE ROOT CAUSE COULD BE DETERMINED AFTER VISUAL EXAMINATION OF THE DEVICE. NO FURTHER ANALYSIS COULD BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A PORTION OF A CSI ORBITAL ATHERECTOMY DEVICE (OAD) AND A PORTION OF A CSI VIPERWIRE GUIDEWIRE WERE LEFT IN THE PATIENT. THE TARGET LESION WAS SEVERELY CALCIFIED, 4CM IN LENGTH AND WAS LOCATED IN THE DISTAL ANTERIOR TIBIAL (AT) ARTERY. THE PHYSICIAN ADVANCED THE CSI VIPERWIRE INTO THE PATIENT AND LOADED THE OAD ONTO THE GUIDEWIRE. THE PHYSICIAN ATTEMPTED TO CROSS THE LESION USING 4 RUNS AT LOW SPEED, BUT WAS UNSUCCESSFUL. THE PHYSICIAN THEN ATTEMPTED TO CROSS THE LESION ON MEDIUM SPEED, BUT WAS STILL UNSUCCESSFUL. THE PHYSICIAN THEN ATTEMPTED TO CROSS THE LESION ON HIGH SPEED, BUT THE TIP OF THE OAD AND 10CM OF THE VIPERWIRE FRACTURED. THE PERONEAL ARTERY HAD BEEN PREVIOUSLY TREATED AND CONTINUED TO HAVE GOOD COLLATERAL FLOW, SO THE TIP OF THE OAD AND 10CM OF VIPERWIRE WERE NOT RETRIEVED AS THEY WERE NOT NEGATIVELY IMPACTING THE PATIENT. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE INTERVENTION. AN ATTEMPT WAS MADE TO GET ADDITIONAL INFORMATION AS WELL AS THE OAD AND VIPERWIRE FOR ANALYSIS. IT IS THE FACILITY POLICY TO RETAIN THE OAD AND VIPERWIRE FOR THEIR INTERNAL RECORDS AND NO INFORMATION WAS PROVIDED TO CSI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591255 DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE MCW CARDIOVASCULAR SYSTEMS INCORPORATED DBP-125MICRO145 106611

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O