BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1941486 · Received December 29, 2010

    Report

    Report Number
    2134265-2010-05859
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: AN EXAMINATION OF THE COMPLAINT CATHETER UNIT WAS CARRIED OUT. IT WAS NOTED ON VISUAL INSPECTION THAT THE HANDSHAKE CONNECTION WAS UNDER THE CATHETER BODY. AN UNSUCCESSFUL ATTEMPT WAS MADE TO RETRIEVE THE HANDSHAKE CONNECTION FROM UNDER THE CATHETER BODY. WHEN THE CATHETER BODY WAS REMOVED FROM THE CATHETER IT WAS NOTED THAT THE HANDSHAKE CONNECTION WAS JAMMED WITHIN THE SHEATH. THE SHEATH WAS CUT OPEN TO RETRIEVE THE HANDSHAKE CONNECTION. THE HANDSHAKE CONNECTION WAS BENT. THE HANDSHAKE CONNECTION OF THE COMPLAINT CATHETER DEVICE WAS ATTACHED TO A TEST ADVANCER. A TUG TEST WAS PERFORMED ON THE HANDSHAKE CONNECTION TO EXAMINE THE INTEGRITY OF THE CONNECTION. THERE WERE NO ISSUES WITH THE CONNECTOR OF THE CATHETER DEVICE WHEN CONNECTED TO THE TEST ADVANCER. 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/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: 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 A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, SPEED ISSUES OCCURRED. THE LESION WAS LOCATED IN A SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 1.25MM ROTABLATOR BURR CATHETER WAS CONNECTED TO THE ADVANCER AND PLATFORM TESTING WAS PERFORMED SUCCESSFULLY. WHEN HE BEGAN ABLATION "SUDDENLY HE FOUND ROTA LOST CONTROL AND SPEED DISPLAY WAS VERY HIGH." ONCE THE BURR WAS WITHDRAWN, IT WAS DISCOVERED THAT THE BURR AND ADVANCER HAD LOST CONNECTION. THE 1.25MM BURR WAS REPLACED WITH A 1.5MM ROTABLATOR BURR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, SPEED ISSUES OCCURRED. THE LESION WAS LOCATED IN A SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 1.25MM ROTABLATOR BURR CATHETER WAS CONNECTED TO THE ADVANCER AND PLATFORM TESTING WAS PERFORMED SUCCESSFULLY. WHEN HE BEGAN ABLATION "SUDDENLY HE FOUND ROTA LOST CONTROL AND SPEED DISPLAY WAS VERY HIGH." ONCE THE BURR WAS WITHDRAWN, IT WAS DISCOVERED THAT THE BURR AND ADVANCER HAD LOST CONNECTION. THE 1.25MM BURR WAS REPLACED WITH A 1.5MM ROTABLATOR BURR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H802227680020 13477440

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR ROTAWIRE GUIDE WIRE