BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK? PLUS

    MDR report key: 4190252 · Received October 21, 2014

    Report

    Report Number
    2134265-2014-06315
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    July 18, 2014
    Report Date
    September 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE COMPLAINT UNIT WAS CARRIED OUT. THE ADVANCER KNOB WAS RETURNED IN A BACKWARD POSITION, IT WAS LOOSENED AND ADVANCED IN ORDER TO INSPECT THE HANDSHAKE CONNECTION. THE HANDSHAKE CONNECTION WAS INSPECTED AND NO DAMAGE WAS NOTED. A HANDSHAKE CONNECTION TEST WAS ATTEMPTED TO EXAMINE THE INTEGRITY OF THE CONNECTION. NO ISSUES WERE NOTED. A GUIDEWIRE WAS RETURNED RUNNING THROUGH THE DEVICE. AN ATTEMPT WAS MADE TO REMOVE THE GUIDEWIRE BUT A RESISTANCE WAS ENCOUNTERED AND THE GUIDEWIRE COULD NOT BE REMOVED. BLOOD WAS RUNNING THROUGH THE SHEATH SURROUNDING THE COIL. THEREFORE THE DEVICE COULD NOT BE WET TESTED. 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: 2134265-2014-06260. THIS COMPLAINT IS NOW REPORTABLE BASED UPON THE DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT THE BURR BECAME STUCK ON WIRE. A 1.75MM ROTALINK¿ PLUS AND 330CM ROTAWIRE¿ AND WIRECLIP¿ TORQUER WERE SELECTED TO TREAT TO TARGET LESION. DURING PROCEDURE, THE FOOTSWITCH WAS STEPPED, HOWEVER, THE BURR DID NOT ROTATE. IT WAS NOTED THE BURR WAS UNABLE TO BE REMOVED FROM THE ROTAWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED A BROKEN WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668674 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310040 0016608183

    Patients

    Seq Age Sex Outcome Treatment
    1