BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 7356002 · Received March 20, 2018

    Report

    Report Number
    2134265-2018-02006
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Report Date
    February 26, 2018
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED: DEVICE LOT NUMBER, DEVICE EXPIRATION DATE, DEVICE MANUFACTURED DATE, DEVICE AVAIL. FOR EVAL, RETURNED TO MFR. ON,  DEVICE RETURNED TO MFR., DEVICE EVALUATED BY MFR., EVAL SUMMARY ATTACHED, METHOD CODES, RESULTS CODES, CONCLUSION CODES. DEVICE EVALUATED BY MFR: ROTABLATOR CONSOLE INSPECTION WAS PERFORMED BASED ON THE RECEIVING INSPECTION MANUAL. VISUAL INSPECTION FOUND THE CONSOLE WAS IN OVERALL GOOD PHYSICAL CONDITION. THE CONSOLE PASSED FULL FUNCTIONAL TESTING. ALL INDICATORS OPERATIONAL WITH THE FULL CONTROL OVER THE SPEED. PRESSURE REGULATOR INSPECTION WAS PERFORMED BASED ON FUNCTIONAL TEST. VISUAL INSPECTION FOUND THE PRESSURE REGULATOR WAS IN OVERALL GOOD PHYSICAL CONDITION. GAS CYLINDER AND OUTPUT PRESSURE CONNECTIONS IN GOOD CONDITION. NO AIR LEAKS DETECTED. PRESSURE WAS ADJUSTED WITH NO ISSUES. GAS FLOW EVEN AND CONTROLLED. THE REGULATOR OPERATED WITH NO ISSUES. THE SYSTEM COULD CONTROL THE REGULATOR THE SPEED WITH NO ISSUES. THE INVESTIGATION CONCLUSION IS NOT CONFIRMED - RETURNED AS THERE WAS NO EVIDENCE OF EITHER THE ALLEGED ISSUE(S) OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPEED WAS UNSTABLE. A ROTABLATOR CONSOLE KIT WAS SELECTED FOR USE DURING A PROCEDURE. IT WAS USED ALONG WITH A BOSTON SCIENTIFIC HTI REGULATOR KIT. IT WAS NOTICED DURING THE PROCEDURE THAT THE ROTATION SPEED WAS NOT STABLE. PRESSURE ADJUSTMENT WAS PERFORMED BY USING THE REGULATOR, AND THE ROTATION SPEED WAS ADJUSTED, HOWEVER DURING ABLATION THE SET ROTATION SPEED SIGNIFICANTLY INCREASED OR IT SIGNIFICANTLY DECREASED. NO PATIENT COMPLICATIONS WERE REPORTED. THE SAME ISSUE OCCURRED DURING A PREVIOUS PROCEDURE AS WELL, IN TOTAL DURING TWO SEPARATE PROCEDURES. THE CYLINDER AND REGULATOR HAD BEEN PREVIOUSLY REPLACED, WITHOUT RESOLVING THE ISSUE, SO THE CONSOLE WAS SUSPECTED TO BE DEFECTIVE.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPEED WAS UNSTABLE. A ROTABLATOR CONSOLE KIT WAS SELECTED FOR USE DURING A PROCEDURE. IT WAS USED ALONG WITH A BOSTON SCIENTIFIC HTI REGULATOR KIT. IT WAS NOTICED DURING THE PROCEDURE THAT THE ROTATION SPEED WAS NOT STABLE. PRESSURE ADJUSTMENT WAS PERFORMED BY USING THE REGULATOR, AND THE ROTATION SPEED WAS ADJUSTED, HOWEVER DURING ABLATION THE SET ROTATION SPEED SIGNIFICANTLY INCREASED OR IT SIGNIFICANTLY DECREASED. NO PATIENT COMPLICATIONS WERE REPORTED.THE SAME ISSUE OCCURRED DURING A PREVIOUS PROCEDURE AS WELL, IN TOTAL DURING TWO SEPARATE PROCEDURES. THE CYLINDER AND REGULATOR HAD BEEN PREVIOUSLY REPLACED, WITHOUT RESOLVING THE ISSUE, SO THE CONSOLE WAS SUSPECTED TO BE DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198249 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - FREMONT (CE) H802220200391 RC401258

    Patients

    Seq Age Sex Outcome Treatment
    1