BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 4093993 · Received September 16, 2014

    Report

    Report Number
    2134265-2014-05489
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    July 18, 2014
    Report Date
    August 22, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE WAS RETURNED IN A GENERIC PLASTIC BAG. VISUAL AND TACTILE INSPECTION WAS PERFORMED AND THE DEVICE RETURNED STUCK INSIDE THE CATHETER AND COULD NOT BE REMOVED FROM THE CATHETER. HOWEVER, DEVICE PRESENTS A BODY KINKED, COILWIRE UNRAVELED AND COREWIRE BROKEN. THE OUTER DIAMETER OF THE MED SECTION COULD NOT BE MEASURED SINCE THIS SECTION WAS STUCK INSIDE THE CATHETER. THE OUTER DIAMETER OF THE SPRING TIP COULD NOT BE MEASURED SINCE THIS WAS RETURNED SEVERELY DAMAGED. ALL THE OUTER DIAMETER MEASUREMENTS ARE WITHIN THE SPECIFICATIONS. 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 BURR STUCK ON WIRE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WAS USED TO ADVANCE TO THE TARGET LESION. DURING PROCEDURE WHILE DYNAGLIDING, THE BURR STALLED AND UPON REMOVAL OF THE BURR, IT WOULD NOT DYNAGLIDE OUT AND IT WAS THEN NOTED THAT THE BURR WAS STUCK ON THE ROTAWIRE. THE ROTAWIRE AND THE BURR WERE REMOVED TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A COREWIRE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571606 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK509

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR