BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK? BURR

    MDR report key: 4143374 · Received October 6, 2014

    Report

    Report Number
    2134265-2014-05903
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.; A VISUAL EXAMINATION OF THE COMPLAINT UNIT WAS CARRIED OUT AND NO ISSUES WERE NOTED. THE HANDSHAKE CONNECTION WAS INSPECTED AND NO DAMAGE WAS NOTED. THE ANNULUS OF THE BURR WAS INSPECTED AND WAS OBSERVED TO BE DAMAGED. THE BURR WAS SOAKED IN HOT WATER IN ORDER TO DISSOLVE ANY RESIDUAL DRIED SALINE. A TEST GUIDEWIRE WAS SUCCESSFULLY LOADED THROUGH THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME MDR ID AS 2134265-2014-05902. IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED. A 330CM ROTAWIRE¿ AND WIRECLIP¿ TORQUER AND A 1.50MM ROTALINK¿ BURR WERE SELECTED TO TREAT THE LESION. UPON PLATFORMING, IT WAS NOTED THAT THE BURR CUT THE WIRE. THE PHYSICIAN PULLED THE WIRE COMPLETELY OUT OF THE BODY AND ANOTHER WIRE WAS USED TO RUN THE BURR OVER THE NEW WIRE. HOWEVER, IT WOULD NOT TRACK OVER THE WIRE, THE PHYSICIAN HAD TO USE A NEW BURR. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    SAME MDR ID AS 2134265-2014-05902. IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED. A 330CM ROTAWIRE¿ AND WIRECLIP¿ TORQUER AND A 1.50MM ROTALINK¿ BURR WERE SELECTED TO TREAT THE LESION. UPON PLATFORMING, IT WAS NOTED THAT THE BURR CUT THE WIRE. THE PHYSICIAN PULLED THE WIRE COMPLETELY OUT OF THE BODY AND ANOTHER WIRE WAS USED TO RUN THE BURR OVER THE NEW WIRE. HOWEVER, IT WOULD NOT TRACK OVER THE WIRE, THE PHYSICIAN HAD TO USE A NEW BURR. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622622 ROTALINK? BURR CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H802227680030 0017145003

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR ROTAWIRE 330CM - GUIDEWIRE