BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTAPRO

    MDR report key: 11516492 · Received March 18, 2021

    Report

    Report Number
    2134265-2021-03517
    Event Type
    Malfunction
    Date Received
    March 18, 2021
    Date of Event
    February 23, 2021
    Report Date
    April 21, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCX
    UDI-DI
    08714729893356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT: EVENT DATE WAS REPORTED AS 1 TO 2 DAYS PRIOR TO (B)(6) 2021. DATE WAS APPROXIMATED TO (B)(6) 2021. AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: THE RETURNED PRODUCT CONSISTED OF THE ROTAPRO ADVANCER ATHERECTOMY SYSTEM. THE BURR CATHETER WAS NOT RETURNED FOR ANALYSIS. THE ADVANCER, DRIVE SHAFT, AND HANDSHAKE CONNECTION WERE VISUALLY AND MICROSCOPICALLY EXAMINED. INSPECTION OF THE DEVICE REVEALED THAT THE HANDSHAKE CONNECTION WAS BENT AT THE HOUSING. WHEN RECEIVED, THE KNOB SWITCH WAS TIGHTENED DOWN IN THE FORWARD POSITION. IT WAS MOST LIKELY THAT WHEN THE DEVICE WAS PLACED IN THE BIOHAZARD BAG FOR RETURN, THE HANDSHAKE CONNECTION WAS BENT AS IT WAS PROTRUDING FROM THE HOUSING. FUNCTIONAL TESTING WAS PERFORMED BY ATTEMPTING TO ROTATE THE DRIVE SHAFT AND THE DRIVE SHAFT WAS ABLE TO ROTATE. THEN FUNCTIONAL TESTING WAS PERFORMED BY CONNECTING THE ROTAPRO ADVANCER TO THE ROTAPRO CONTROL CONSOLE SYSTEM. WHEN THE KNOB SWITCH, ABLATION BUTTON, WAS PUSHED, THE ADVANCER DID NOT GET ANY SPEED AND A STALL ERROR WAS DISPLAYED ON THE CONSOLE. THE ADVANCER WAS DISMANTLED AND THE COMPONENTS INSIDE THE ADVANCER WERE INSPECTED AND THE TURBINE WAS FOUND TO BE CORRODED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BURR SPEED EXCEEDED THE SET SPEED. A 1.50MM ROTAPRO WAS SELECTED FOR USE IN AN ATHERECTOMY PROCEDURE. THE BURR WAS SET TO A SPEED OF 160,000 RPM OUTSIDE OF THE PATIENT. THE BURR WAS THEN ADVANCED TO THE TARGET LESION. WHEN THE BURR WAS ACTIVATED PROXIMAL TO THE LESION, THE SPEED WAS NOTED TO BE CLOSE TO 200,000 RPM. THERE WAS NO HARM TO THE PATIENT, AND ONLY A MINIMAL DELAY IN COMPLETING THE PROCEDURE. IT WAS FURTHER REPORTED THAT ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EVENT DATE WAS NOT REPORTED AND WAS APPROXIMATED TO (B)(6) 2021.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BURR SPEED EXCEEDED THE SET SPEED. A 1.50MM ROTAPRO WAS SELECTED FOR USE IN AN ATHERECTOMY PROCEDURE. THE BURR WAS SET TO A SPEED OF 160,000 RPM OUTSIDE OF THE PATIENT. THE BURR WAS THEN ADVANCED TO THE TARGET LESION. WHEN THE BURR WAS ACTIVATED PROXIMAL TO THE LESION, THE SPEED WAS NOTED TO BE CLOSE TO 200,000 RPM. THERE WAS NO HARM TO THE PATIENT, AND ONLY A MINIMAL DELAY IN COMPLETING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415618 ROTAPRO CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC CORPORATION 39467-150 0026651313 08714729893356

    Patients

    Seq Age Sex Outcome Treatment
    1