BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK? PLUS

    MDR report key: 4173572 · Received October 15, 2014

    Report

    Report Number
    2134265-2014-06675
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    May 26, 2014
    Report Date
    September 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION WAS PERFORMED. A GUIDEWIRE WAS RETURNED RUNNING THROUGH THE DEVICE. THIS WAS REMOVED WITH NO RESISTANCE ENCOUNTERED. THE HANDSHAKE CONNECTION WAS INSPECTED AND NO ISSUES WERE NOTED. THE ANNULUS OF THE BURR WAS INSPECTED AND WAS OBSERVED TO BE DAMAGED AND BLOCKED. THE BLOCKAGE MAY BE DUE TO A FRACTURED GUIDEWIRE. 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).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID:2134265-2014-06682. REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16SEPT2014. IT WAS REPORTED THAT THE BURR WAS UNABLE TO ABLATE THE LESION AND RESISTANCE WAS ENCOUNTERED UPON ADVANCING THE BURR INTO THE ROTAWIRE. A 330CM ROTAWIRE¿ AND WIRECLIP¿ TORQUER AND A 1.25MM ROTALINK¿ PLUS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE "HIGHLY" CALCIFIED MID RIGHT CORONARY ARTERY. DURING PROCEDURE, THE PHYSICIAN TRIED DEBULKING THE LESION WITH A 1.25MM ROTALINK PLUS BUT THIS DEVICE WAS UNABLE TO ABLATE THE LESION. THE BURR WAS THEN REPLACED WITH ANOTHER 1.25MM BURR AND THE SAME ISSUE WAS OBSERVED. IT WAS THEN NOTED THAT RESISTANCE WAS ENCOUNTERED UPON ADVANCING THE BURR INTO THE ROTAWIRE. PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A DAMAGED/BLOCKED ANNULUS OF THE BURR POSSIBLY DUE TO A FRACTURED GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653669 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310020 0016783753

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR