BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE¿

    MDR report key: 2915705 · Received January 15, 2013

    Report

    Report Number
    2134265-2012-08460
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Report Date
    December 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 AN ANGIOPLASTY PROCEDURE, DEFLATION ISSUES OCCURRED. THE PHYSICIAN INFLATED A 15MM X 2.00MM EMERGE BALLOON CATHETER IN THE TARGET LESION. WHEN THE PHYSICIAN ATTEMPTED TO DEFLATE THE BALLOON, IT WAS SLOW OR FAILED TO DEFLATE. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22320 EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493919115200 14912359

    Patients

    Seq Age Sex Outcome Treatment
    1