BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 4111594 · Received September 23, 2014

    Report

    Report Number
    2134265-2014-05638
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    June 26, 2014
    Report Date
    August 29, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL AND TACTILE INSPECTION WAS PERFORMED. THE SPRING TIP DETACHED AND THE BODY KINKED. THERE IS NO EVIDENCE OF FRACTURE ON THE COREWIRE AND THE SPRING TIP WAS NOT RETURNED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT THE ROTAWIRE WAS UNABLE TO ADVANCE IN THE CATHETER. A ROTAWIRE WAS USED TO TREAT THE TARGET LESION. DURING PROCEDURE OF A PERCUTANEOUS CORONARY INTERVENTION, A 1.2MM BURR WAS USED FOR ABLATION. THE SIZE WAS THEN INCREASED TO 1.5MM AND BACK TO 1.2MM. UPON LOADING OF THE BURR THROUGH THE GUIDEWIRE, THE ROTAWIRE WOULD NOT ADVANCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE SAME ISSUE HAPPENED. THE BURR WAS THEN EXCHANGED TO ANOTHER 1.25MM AND USED WITHOUT ISSUES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED A SPRING TIP DETACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592140 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK509

    Patients

    Seq Age Sex Outcome Treatment
    1