BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAPRO

    MDR report key: 11362616 · Received February 22, 2021

    Report

    Report Number
    2134265-2021-02026
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    February 5, 2021
    Report Date
    March 30, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    UDI-DI
    08714729893363
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVAL BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF THE ROTAPRO ATHERECTOMY SYSTEM. THE BURR CATHETER WAS RECEIVED ATTACHED TO THE ADVANCER UNIT. THE ADVANCER, HANDSHAKE CONNECTIONS, SHEATH, COIL, BURR, AND ANNULUS WERE VISUALLY AND MICROSCOPICALLY EXAMINED. INSPECTION PRESENTED NO DAMAGE OR IRREGULARITIES TO THE DEVICE. FUNCTIONAL TESTING WAS PERFORMED BY ATTEMPTING TO ROTATE THE DRIVE SHAFT, AND THE DRIVE SHAFT WAS ABLE TO BE ROTATED. THE ROTAPRO ADVANCER WAS THEN CONNECTED TO THE ROTAPRO CONTROL CONSOLE SYSTEM. THE ADVANCER WAS ABLE TO REACH OPTIMUM SPEED WITHOUT ANY ABNORMAL OR HIGH PITCH NOISES. DURING FUNCTIONAL TESTING, THERE WERE NO ABNORMALITIES TO THE DEVICE, AND IT RAN WITH NO SPEED ISSUES OR ABNORMAL OR HIGH PITCH NOISES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED AND RESCHEDULED POST-SEDATION. TWO 1.50MM ROTAPROS WERE SELECTED FOR USE IN AN ATHERECTOMY PROCEDURE. THE PATIENT WAS SEDATED. DURING SETUP, THE CONSOLE MADE A LOUD NOISE, AND THE 1.50MM ROTAPRO WOULD NOT PLATFORM. THE DEVICE WAS EXCHANGED FOR ANOTHER 1.50MM ROTAPRO, AND THE SAME ISSUE OCCURRED. THE NITROGEN SUPPLY WAS POSSIBLY SET TOO HIGH. AT ONE POINT, THE NITROGEN WAS SET AT 110 PSI, BUT 30 MINUTES LATER, IT WAS NOTED TO BE AT APPROXIMATELY 160 PSI. THE PROCEDURE WAS ABORTED AND RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED. ON FEBRUARY 8TH, 2021, THE PATIENT RETURNED FOR ROTAPRO PROCEDURE. THERE WERE NO ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED AND RESCHEDULED POST-SEDATION. TWO 1.50MM ROTAPROS WERE SELECTED FOR USE IN AN ATHERECTOMY PROCEDURE. THE PATIENT WAS SEDATED. DURING SETUP, THE CONSOLE MADE A LOUD NOISE, AND THE 1.50MM ROTAPRO WOULD NOT PLATFORM. THE DEVICE WAS EXCHANGED FOR ANOTHER 1.50MM ROTAPRO, AND THE SAME ISSUE OCCURRED. THE NITROGEN SUPPLY WAS POSSIBLY SET TOO HIGH. AT ONE POINT, THE NITROGEN WAS SET AT 110 PSI, BUT 30 MINUTES LATER, IT WAS NOTED TO BE AT APPROXIMATELY 160 PSI. THE PROCEDURE WAS ABORTED AND RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED. ON (B)(6) 2021, THE PATIENT RETURNED FOR ROTAPRO PROCEDURE. THERE WERE NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255585 ROTAPRO CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION 3243 0026395949 08714729893363

    Patients

    Seq Age Sex Outcome Treatment
    1