BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE¿

    MDR report key: 2870606 · Received December 12, 2012

    Report

    Report Number
    2134265-2012-07520
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 16, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CAROTID STENTING TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED. THE 80% STENOSED LESION BEING TREATED WAS LOCATED IN THE NON-CALCIFIED, MODERATELY TORTUOUS, RIGHT INTERNAL CAROTID ARTERY. UPON ADVANCING A 20 MM X 4.00 MM EMERGE BALLOON CATHETER, THE DEVICE FRACTURED AT MID SHAFT. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 4.0 X 20 MM NON-BSC BALLOON CATHETER. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493918920400

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR