BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK? PLUS

    MDR report key: 4143368 · Received October 6, 2014

    Report

    Report Number
    2134265-2014-05916
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 9, 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE COMPLAINT UNIT WAS CARRIED OUT AND NO ISSUES WERE NOTED. THE ADVANCER KNOB 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. THE DRIVE SHAFT COIL AND SHEATH WERE INSPECTED AND THERE WAS NO DAMAGE NOTED. THE ANNULUS OF THE BURR WAS INSPECTED AND WAS OBSERVED TO BE DAMAGED. A TEST GUIDEWIRE WAS SUCCESSFULLY LOADED THROUGH THE ENTIRE 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 WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-05917. IT WAS REPORTED THAT A ROTAWIRE DETACHMENT OCCURRED. A 1.50MM ROTALINK¿ PLUS AND 330MM ROTAWIRE FLOPPY WERE SELECTED TO TREAT THE TARGET LESION. DURING PREPARATION OUTSIDE OF THE PATIENT, WHEN ROTATIONAL SPEED WAS CHECKED IT WAS NOTED THAT THE ROTAWIRE HAD DETACHED. IT WAS FURTHER REPORTED THAT THE ROTAWIRE HAD NOT BEEN WAVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2014-05917. IT WAS REPORTED THAT A ROTAWIRE DETACHMENT OCCURRED. A 1.50MM ROTALINK¿ PLUS AND 330MM ROTAWIRE FLOPPY WERE SELECTED TO TREAT THE TARGET LESION. DURING PREPARATION OUTSIDE OF THE PATIENT, WHEN ROTATIONAL SPEED WAS CHECKED IT WAS NOTED THAT THE ROTAWIRE HAD DETACHED. IT WAS FURTHER REPORTED THAT THE ROTAWIRE HAD NOT BEEN WAVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622620 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030 17079872

    Patients

    Seq Age Sex Outcome Treatment
    1