BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 9380427 · Received November 26, 2019

    Report

    Report Number
    3004742232-2019-00308
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Date of Event
    October 29, 2019
    Report Date
    November 26, 2019
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCW
    UDI-DI
    10852528005770
    PMA / PMN Number
    K190634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED OAD WAS RECEIVED FOR ANALYSIS. VISUAL EXAMINATION OF THE DEVICE DID NOT REVEAL ANY DAMAGE. A GUIDE WIRE WAS INSERTED THROUGH THE DRIVESHAFT AND HANDLE ASSEMBLY WITHOUT RESISTANCE. POWER WAS APPLIED TO THE DEVICE AND ALL LED LIGHTS WERE VISIBLY LIT, WITH THE OAD DEFAULTING TO LOW SPEED AS EXPECTED. THE OAD WAS POWERED ON AND OFF SEVERAL TIMES WITHOUT ANY ISSUES OBSERVED. A SALINE SOLUTION WAS POURED OVER THE MOTOR ASSEMBLY AND CABLE SET, AND THE OAD CONTINUED TO SPIN AND FUNCTION AS INTENDED. THE START SWITCH, AND BRAKE ASSEMBLY WERE EXAMINED AND THERE WAS NO DAMAGE OR ABNORMALITIES OBSERVED. AT THE CONCLUSION OF THE DEVICE ANALYSIS INVESTIGATION, THE REPORTS THAT THE OAD SOUNDED AS THOUGH IT WERE INCREASING IN SPEED AND WOULD NOT STOP SPINNING WERE NOT CONFIRMED. 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 PRIOR TO DISTRIBUTION. CSI ID: (B)(4).

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE STEALTH ORBITAL ATHERECTOMY DEVICE (OAD) WAS OPERATED ON MEDIUM SPEED FOR ONE TREATMENT PASS. THE OAD WAS SWITCHED TO HIGH SPEED AND SOUNDED VERY LOUD AS THOUGH IT WERE INCREASING IN SPEED. AN ATTEMPT WAS MADE TO TURN OFF THE OAD USING THE POWER BUTTON, BUT IT WAS UNSUCCESSFUL, AND THE OAD CONTINUED SPINNING. THE SALINE PUMP WAS POWERED OFF, IN ORDER TO CEASE POWER TO THE OAD. THE OAD WAS REMOVED FROM THE SHEATH AND THE PUMP WAS POWERED BACK ON. THIS CAUSED THE OAD TO POWER BACK UP, AND THE SAME ISSUE RECURRED. THE DEVICE WAS REPLACED WITH A SECOND OAD TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174565 DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE MCW CARDIOVASCULAR SYSTEMS, INC. RAD-SC30-175 265106 10852528005770

    Patients

    Seq Age Sex Outcome Treatment
    1