BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1904545 · Received November 22, 2010

    Report

    Report Number
    2134265-2010-05322
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE ROTABLATOR CONSOLE AND FOOT PEDAL WERE TESTED WITH A 1.75MM ROTALINK BURR. THE ROTATIONAL SPEED IN DYNAGLIDE MODE AND TURBINE MODE MET SPECIFICATIONS, MAINTAINING THE RPM SETTING. EXAMINATION IDENTIFIED A SLIGHT GAS/AIR LEAK WHEN THE PNEUMATIC CIRCUIT WAS CHARGED AND THE CONSOLE SUPPLY SHUT OFF. THE LEAK RATE WAS WITHIN SPECIFICATIONS. THE FOOT PEDAL FUNCTIONED PROPERLY, READILY ACTIVATING/DEACTIVATING THE BURR ROTATION AND SWITCHING THE CONSOLE BETWEEN TURBINE AND DYNAGLIDE MODES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS NOT CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR.: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID # 2134265-2010-05378 IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), SPEED ISSUES OCCURRED. THE 98% STENOSED LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY (RCA) ARTERY. DURING PREP THE ROTABLATOR CONSOLE AND THE 1.25MM ROTABLATOR ROTALINK PLUS PLATFORMED AT 160,000 RPMS. THE PHYSICIAN ADVANCED THE ROTALINK PLUS AND SUCCESSFULLY COMPLETED FIVE TO SIX ABLATIONS WITH EACH ABLATION APPROXIMATELY 20-30 SECONDS LONG. THE RPM SPEED THEN BEGAN TO FLUCTUATE ABOVE AND BELOW THE DESIRED SPEEDS. THE SPEED WOULD DECREASE TO 40,000-50,000 RPMS AND THEN INCREASE UP TO 150,000 RPMS. THE PHYSICIAN THOUGHT HE HEARD AN AIR LEAK. AFTER THE FIRST SPEED FLUCTUATION, THE SPEED WAS READJUSTED TO 160,000 RPMS HOWEVER, THE BURR STALLED. AFTER THE SECOND SPEED FLUCTUATION, THE SPEED WAS READJUSTED TO 160,000 RPMS HOWEVER; THE PHYSICIAN OPTED TO DYNAGLIDE OUT DUE TO THE SPEED CONTINUING TO FLUCTUATE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID # 2134265-2010-05378. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), SPEED ISSUES OCCURRED. THE 98% STENOSED LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY (RCA) ARTERY. DURING PREP THE ROTABLATOR CONSOLE AND THE 1.25MM ROTABLATOR ROTALINK PLUS PLATFORMED AT 160,000 RPMS. THE PHYSICIAN ADVANCED THE ROTALINK PLUS AND SUCCESSFULLY COMPLETED FIVE TO SIX ABLATIONS WITH EACH ABLATION APPROXIMATELY 20-30 SECONDS LONG. THE RPM SPEED THEN BEGAN TO FLUCTUATE ABOVE AND BELOW THE DESIRED SPEEDS. THE SPEED WOULD DECREASE TO 40,000-50,000 RPMS AND THEN INCREASE UP TO 150,000 RPMS. THE PHYSICIAN THOUGHT HE HEARD AN AIR LEAK. AFTER THE FIRST SPEED FLUCTUATION, THE SPEED WAS READJUSTED TO 160,000 RPMS HOWEVER, THE BURR STALLED. AFTER THE SECOND SPEED FLUCTUATION, THE SPEED WAS READJUSTED TO 160,000 RPMS HOWEVER; THE PHYSICIAN OPTED TO DYNAGLIDE OUT DUE TO THE SPEED CONTINUING TO FLUCTUATE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID # 2134265-2010-05378. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI), SPEED ISSUES OCCURRED. THE 98% STENOSED LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY (RCA) ARTERY. DURING PREP THE ROTABLATOR CONSOLE AND THE 1.25MM ROTABLATOR ROTALINK PLUS PLATFORMED AT 160,000 RPMS. THE PHYSICIAN ADVANCED THE ROTALINK PLUS AND SUCCESSFULLY COMPLETED FIVE TO SIX ABLATIONS WITH EACH ABLATION APPROXIMATELY 20-30 SECONDS LONG. THE RPM SPEED THEN BEGAN TO FLUCTUATE ABOVE AND BELOW THE DESIRED SPEEDS. THE SPEED WOULD DECREASE TO 40,000-50,000 RPMS AND THEN INCREASE UP TO 150,000 RPMS. THE PHYSICIAN THOUGHT HE HEARD AN AIR LEAK. AFTER THE FIRST SPEED FLUCTUATION, THE SPEED WAS READJUSTED TO 160,000 RPMS HOWEVER, THE BURR STALLED. AFTER THE SECOND SPEED FLUCTUATION, THE SPEED WAS READJUSTED TO 160,000 RPMS HOWEVER; THE PHYSICIAN OPTED TO DYNAGLIDE OUT DUE TO THE SPEED CONTINUING TO FLUCTUATE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - FREMONT 22020-029-R RC-3859

    Patients

    Seq Age Sex Outcome Treatment
    1 1.25MM ROTABLATOR ROTALINK PLUS