BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 9654046 · Received January 31, 2020

    Report

    Report Number
    3004742232-2020-00025
    Event Type
    Malfunction
    Date Received
    January 31, 2020
    Date of Event
    January 8, 2020
    Report Date
    January 31, 2020
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCW
    UDI-DI
    10850000491264
    PMA / PMN Number
    K190634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED OAD WAS RECEIVED FOR ANALYSIS. THERE WERE NO DAMAGES THAT WERE VISUALLY OBSERVED. THE OAD WAS TESTED, SPUN AT ALL SPEEDS, AND TURNED OFF WITH NO ISSUE OBSERVED. THE START SWITCH WAS MANUALLY DEPRESSED WITH AN INCREASED AMOUNT OF PRESSURE, HOWEVER, THIS DID NOT CAUSE THE DOME TO REMAIN IN THE DEPRESSED STATE AND, THE OAD FUNCTIONED AS INTENDED. THE DATA DOWNLOAD FROM THE OAD REVEALED THAT THE START SWITCH HAD REMAINED IN A DEPRESSED STATE DURING THE EVENT, WHICH PREVENTED THE START SWITCH FROM STOPPING THE OPERATION OF THE DEVICE. THIS WAS UNABLE TO BE RECREATED DURING ANALYSIS. AT THE CONCLUSION OF THE DEVICE ANALYSIS, THE REPORTED EVENT WHERE THE OAD WOULD NOT STOP SPINNING WAS 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. (B)(4).

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WOULD NOT TURN OFF WHEN THE POWER BUTTON WAS PUSHED. THE OAD WAS USED TO TREAT A 60% STENOSED, MODERATELY CALCIFIED TARGET LESION IN THE POPLITEAL ARTERY THAT WAS 5 MM IN DIAMETER. AFTER THE SIXTH TREATMENT PASS, THE OAD WOULD NOT TURN OFF WHEN THE POWER BUTTON WAS PUSHED, AND THE OAD WAS STOPPED BY TURNING OFF THE SALINE INFUSION PUMP. THE PUMP WAS RESTARTED, AND THE OAD WOULD NOT START SPINNING WHEN THE POWER BUTTON WAS PUSHED. IT WAS CONFIRMED THAT ALL LIGHTS ON THE OAD WERE FUNCTIONING, THE BRAKE WAS DOWN, AND ALL CONNECTIONS WERE SECURE. THE OAD WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SECOND OAD. ADDITIONAL TROUBLESHOOTING WAS PERFORMED WITH THE INITIAL OAD OUTSIDE OF THE PATIENT, HOWEVER, THE DEVICE WOULD STILL NOT SPIN. IT WAS NOTED THAT THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115567 STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE MCW CARDIOVASCULAR SYSTEMS, INC. PRD-SC30-MICRO 289158 10850000491264

    Patients

    Seq Age Sex Outcome Treatment
    1