BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAPRO

    MDR report key: 15625836 · Received October 18, 2022

    Report

    Report Number
    2124215-2022-42109
    Event Type
    Malfunction
    Date Received
    October 18, 2022
    Date of Event
    September 27, 2022
    Report Date
    November 8, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    UDI-DI
    08714729893356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF THE ROTAPRO ATHERECTOMY DEVICE. THE BURR CATHETER WAS RECEIVED ATTACHED TO THE ADVANCER UNIT. THE ADVANCER, HANDSHAKE CONNECTIONS, SHEATH, COIL, BURR AND ANNULUS WERE VISUALLY EXAMINED. INSPECTION OF THE DEVICE FOUND NO DAMAGES OR DEFECTS. FUNCTIONAL TESTING WAS THEN PERFORMED BY CONNECTING THE ADVANCER TO THE ROTAPRO CONTROL CONSOLE. DURING FUNCTIONAL TESTING, THE DEVICE WAS ABLE TO REACH AND MAINTAIN OPTIMAL RPM IN BOTH NORMAL AND DYNAGLIDE MODES WITH NO RESISTANCE OR ISSUES. PRODUCT ANALYSIS DID NOT CONFIRM THE REPORTED EVENT, AS THE DEVICE WAS ABLE TO REACH AND MAINTAIN OPTIMAL RPM WITH NO RESISTANCE OR ISSUES DURING ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSTABLE SPEED OCCURRED. A ROTAPRO 1.50MM ATHERECTOMY CATHETER WAS SELECTED FOR TREATMENT TO A LESION IN A LEFT CORONARY ARTERY. THE ROTAPRO 1.50MM ATHERECTOMY PASSED THE LESION 2-3 TIMES AT 160 MHX. ON THE 3RD OR 4TH TIME THE ROTATIONAL SPEED WAS INCREASED BY TURNING THE KNOB OF THE MOTOR. THE SPEED JUMPED TO 170 MHZ AS THE KNOB WAS BEING TURNED SLOWLY. THE PHYSICIAN ATTEMPTED TO STOP ROTATION OF THE 1.50MM BURR. THE 1.50MM BURR WOULD NOT STOP SPINNING. THE PHYSICIAN HAD TO MANUALLY UNPLUG THE MOTOR. THE PROCEDURE WAS COMPLETED VIA AN ALTERNATIVE METHOD. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSTABLE SPEED OCCURRED. A ROTAPRO 1.50MM ATHERECTOMY CATHETER WAS SELECTED FOR TREATMENT TO A LESION IN A LEFT CORONARY ARTERY. THE ROTAPRO 1.50MM ATHERECTOMY PASSED THE LESION 2-3 TIMES AT 160 MHX. ON THE 3RD OR 4TH TIME THE ROTATIONAL SPEED WAS INCREASED BY TURNING THE KNOB OF THE MOTOR. THE SPEED JUMPED TO 170 MHZ AS THE KNOB WAS BEING TURNED SLOWLY. THE PHYSICIAN ATTEMPTED TO STOP ROTATION OF THE 1.50MM BURR. THE 1.50MM BURR WOULD NOT STOP SPINNING. THE PHYSICIAN HAD TO MANUALLY UNPLUG THE MOTOR. THE PROCEDURE WAS COMPLETED VIA AN ALTERNATIVE METHOD. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2264056 ROTAPRO CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION 39467-150 0029395438 08714729893356

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female