BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE?

    MDR report key: 3173155 · Received June 17, 2013

    Report

    Report Number
    2134265-2013-04170
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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 PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. THE LOCATION OF THE NON-CALCIFIED TARGET LESION WAS UNSPECIFIED. A 1.50MM X 12MM EMERGE MR BALLOON CATHETER WAS USED TO TREAT THE TARGET LESION. UPON INFLATION THE BALLOON RUPTURED AT NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274080 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493919312150 15903566

    Patients

    Seq Age Sex Outcome Treatment
    1