BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 2001286 · Received February 24, 2011

    Report

    Report Number
    2134265-2011-00544
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Report Date
    January 28, 2011
    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 EVALUATION BY MANUFACTURER: AN EXAMINATION OF THE COMPLAINT UNIT WAS NOT CARRIED OUT AS THE PRODUCT WAS NOT RETURNED TO SITE FOR INVESTIGATION. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID#: 2134265-2011-00540. IT WAS REPORTED THAT IN PREPARATION FOR A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. NO LESION OR ANATOMY DETAILS ARE AVAILABLE. DURING ROTATIONAL SPEED TESTING OF THE ROTALINK PLUS BURR OUTSIDE OF THE BODY, THE EXTRA SUPPORT ROTAWIRE GUIDE WIRE FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SET OF THE SAME DEVICES. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK UNK376

    Patients

    Seq Age Sex Outcome Treatment
    1