BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK¿ PLUS

    MDR report key: 2872305 · Received December 13, 2012

    Report

    Report Number
    2134265-2012-07417
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 15, 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

    DEVICE EVALUATED BY MANUFACTURER: AN INITIAL EXAMINATION OF THE COMPLAINT PLUS UNIT WAS CARRIED OUT. A TUG TEST WAS PERFORMED TO EXAMINE THE INTEGRITY OF THE CONNECTION, NO ISSUES WERE NOTED WITH THE UNIT HANDSHAKE CONNECTORS. AN ATTEMPT WAS MADE TO WIRE GUIDE THE BURR UNIT USING A TEST GUIDE WIRE. RESISTANCE WAS MET IN THE ANNULUS OF THE BURR. THE BURR WAS MICROSCOPICALLY EXAMINED AND FOUND THE ANNULUS WAS FLARED/MISSHAPEN. THERE WERE NO SCRATCHES THAT EXPOSED BRASS ON THE PLATED BACK HALF OF THE BURR. A SCRATCH TEST WAS PERFORMED WHICH CONFIRMED THAT THE BURRS' CUTTING ACTION WAS ACCEPTABLE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DIRECTION FOR USE (DFU) WARNS: "NEVER ADVANCE THE ROTATING BURR TO THE POINT OF CONTACT WITH THE GUIDEWIRE SPRING TIP. SUCH CONTACT COULD RESULT IN DISTAL DETACHMENT AND EMBOLIZATION OF THE TIP." "ALWAYS KEEP THE BURR ADVANCING OR RETRACTING WHILE IT IS ROTATING. MAINTAINING THE BURR IN ONE LOCATION WHILE IT IS ROTATING MAY LEAD TO EXCESSIVE TISSUE REMOVAL OR DAMAGE TO THE ROTABLATOR SYSTEM". "COMPLICATIONS ASSOCIATED WITH THE GUIDEWIRE INCLUDES DISTORTION, KINKS, AND FRACTURE". THEREFORE, THE MOST PROBABLE ROOT CAUSE IS USER RELATED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2012-07404. IT WAS REPORTED THAT DURING PREP FOR A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE ROTAWIRE GUIDE WIRE FRACTURED. THE TARGET LESION WAS LOCATED IN AN UNSPECIFIED VESSEL. DURING ROTATIONAL TESTING OF THE 1.75MM ROTABLATOR ROTALINK PLUS AND THE 330CM ROTAWIRE, OUTSIDE OF THE PATIENT, THE GUIDE WIRE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 H749236310040 15343840

    Patients

    Seq Age Sex Outcome Treatment
    1