BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAPRO

    MDR report key: 11597371 · Received March 31, 2021

    Report

    Report Number
    2134265-2021-04127
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    March 10, 2021
    Report Date
    March 31, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    UDI-DI
    08714729893363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT - 18 YEARS OR OLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROTATION SPEED WAS UNSTABLE. A ROTAPRO 1.50MM WAS SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR THE TREATMENT OF CORONARY ARTERY DISEASE. THE TARGET LESION WAS CALCIFIED. DURING THE PROCEDURE, PLATFORMING WAS COMPLETED OUTSIDE THE PATIENT. THE PROCEDURAL TARGET SPEED WAS 170,000 ROTATIONS PER MINUTE (RPM). ONCE INSIDE THE PATIENT, THE PLATFORMING SPEED WAS UNSTABLE, REACHING ABOUT 218,000 RPM. THE SPEED CHANGE WAS AUDIBLE AND THE SALINE DRIP WAS RUNNING. THE SPEED WOULD NOT COME DOWN. THE DEVICE WAS REMOVED AND A NEW SYSTEM WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO VISIBLE DEFECTS. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494616 ROTAPRO CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION 3243 0026477326 08714729893363

    Patients

    Seq Age Sex Outcome Treatment
    1