BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK¿ PLUS

    MDR report key: 2770683 · Received October 3, 2012

    Report

    Report Number
    2134265-2012-06094
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 7, 2012
    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

    AN INITIAL EXAMINATION WAS PERFORMED NO ISSUES WERE NOTED WITH THE UNIT'S HANDSHAKE CONNECTOR DURING THE CONNECTION OF THE DEVICE. AN ATTEMPT WAS MADE TO LOAD A TEST GUIDEWIRE ONTO THE RETURNED UNIT. RESISTANCE WAS MET IN THE ANNULUS OF THE BURR. THE BURR WAS MICROSCOPICALLY EXAMINED AND FOUND THE BURR WAS FLARED/MISSHAPEN. THERE WERE NO SCRATCHES THAT EXPOSED BRASS ON THE PLATED BACK HALF OF THE BURR. THE ROTABLATOR PLUS UNIT WAS WET TESTED, NO ABNORMAL NOISE OR ISSUES WERE NOTED WITH THE WET TESTING OF THE RETURNED PLUS DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DIRECTION FOR USE (DFU) RECOMMENDS USING A 1.50MM DEVICE AT A SPEED OF 160,000 RPM TO 180,000RPM. THE EVENT DESCRIPTION STATES THE DEVICE WAS TESTED AT 220,000RPM. THIS MAY HAVE CONTRIBUTED TO THE GUIDEWIRE FRACTURE ISSUE; THEREFORE, THE MOST PROBABLE ROOT CAUSE IS USER ERROR. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2012-06095. IT WAS REPORTED THAT DURING PREP FOR A ROTATIONAL ATHERECTOMY PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS, CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN ADVANCED A 1.5MM ROTALINK BURR OVER A 330MM ROTAWIRE FLOPPY GUIDE WIRE. DURING THE ROTATIONAL TEST AT APPROXIMATELY 220,000 RPM, THE BURR MADE AN ABNORMAL NOISE AND THE GUIDE WIRE FRACTURED. THE PHYSICIAN TRIED TO LOAD THE BURR ONTO A NEW GUIDE WIRE BUT SEVERE RESISTANCE WAS MET. THE PROCEDURE WAS COMPLETED USING A NEW BURR AND GUIDE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTALINK¿ PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030 15229802

    Patients

    Seq Age Sex Outcome Treatment
    1 330CM ROTAWIRE FLOPPY