BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE?

    MDR report key: 3833737 · Received May 27, 2014

    Report

    Report Number
    2134265-2014-02840
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: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 SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN AN UNSPECIFIED CORONARY ARTERY. A 2.00MM X 12MM EMERGE¿ BALLOON CATHETER WAS SELECTED TO DILATE THE LESION. DURING THE PROCEDURE, THE BALLOON SHAFT BROKE UPON INSERTION INTO THE GUIDE CATHETER. THE PHYSICIAN PULLED BOTH PIECES OUT AND USED A DIFFERENT BALLOON AND THE SAME GUIDE CATHETER TO FINISH THE CASE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310214 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493918912200 16546616

    Patients

    Seq Age Sex Outcome Treatment
    1