BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK¿ PLUS

    MDR report key: 2863121 · Received December 10, 2012

    Report

    Report Number
    2134265-2012-07349
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE ROTABLATOR PLUS UNIT WAS RETURNED CONNECTED. THE BURR COULD NOT BE MICROSCOPICALLY EXAMINED AS THE BURR WAS NOT RETURNED TO SITE FOR INVESTIGATION. THE COIL WAS MICROSCOPICALLY EXAMINED. THE COIL WAS STRETCHED AND DAMAGED WHERE THE BURR WAS DETACHED. THE ROTABLATOR PLUS UNIT COULD NOT BE TESTED DUE TO THE DETACHED BURR. 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

    IT WAS REPORTED THAT DURING THE PREPARATION FOR A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE DEVICE BROKE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PREPARATION FOR A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE DEVICE BROKE.NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTALINK¿ PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030 0015469702

    Patients

    Seq Age Sex Outcome Treatment
    1