BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2840311 · Received November 20, 2012

    Report

    Report Number
    2134265-2012-07161
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: VISUAL EXAMINATION REVEALED THAT THERE WAS CUSTOMER TAP ON THE LABELS AND THE TURBINE RECEPTACLE WAS LOOSE. FUNCTIONAL TESTING REVEALED THAT THE TURBINE ROTATIONAL INITIAL SPEED OF 224K RPMS SLOWLY DECAYS TO 214K RPMS. THE ROTATIONAL SPEED CONTROL IS NONLINEAR WHEN DECREASING FROM MAXIMUM RPM. THE TURBINE PRESSURE CONTROL KNOB REQUIRES EXTRA TURNS BEFORE THE PRESSURE GAUGE READING REGISTERS A DROP IN PRESSURE AND THE ROTATIONAL SPEED DISPLAY REGISTERS A DROP RPMS. IN THE CASE OF THIS CONSOLE, THE ROTATIONAL SPEED ABRUPTLY DROPS TO 174K RPMS FROM MAXIMUM OF 224K RPMS. THE ROTATIONAL SPEED CONTROL IS LINEAR WHEN INCREASING RPMS FROM MINIMUM TO MAXIMUM. THE MOST LIKELY ROOT CAUSE OF THE DROP IN SPEED IS THE PROPORTIONAL VALVE DUE TO NORMAL WEAR AND TEAR. THE ROTATIONAL SPEED AND EVENT TIMER FUNCTIONED PROPERLY. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL AND/OR PROCEDURAL FACTORS. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED THAT DURING PREPARATION FOR A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE DISPLAY ISSUES OCCURRED. A ROTALINK PLUS SYSTEM WAS CONNECTED TO THE ROTABLATOR CONSOLE AND THE EVENT TIMER DISPLAYED 00.00 SECONDS. DURING TESTING OF THE BURR'S ROTATIONAL SPEED THE RPM DISPLAY WAS BLANK AND THE EVENT TIMER DISPLAY DID NOT INCREASE FROM 00.00. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT OBTAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, DISPLAY ISSUES OCCURRED. A ROTALINK PLUS SYSTEM WAS CONNECTED TO THE ROTABLATOR CONSOLE AND THE EVENT TIMER DISPLAYED 00.00 SECONDS. DURING TESTING OF THE BURR'S ROTATIONAL SPEED THE RPM DISPLAY WAS BLANK AND THE EVENT TIMER DISPLAY DID NOT INCREASE FROM 00.00. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - FREMONT (CE) H802220200381 RC105634

    Patients

    Seq Age Sex Outcome Treatment
    1 ROTALINK PLUS ABLATION CATHETER