BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE?

    MDR report key: 3881700 · Received June 18, 2014

    Report

    Report Number
    2134265-2014-03836
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    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. 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 BALLOON RUPTURE OCCURRED. THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS TARGET LESION WAS A 99% IN-STENT RESTENOSIS OF AN UNSPECIFIED STENT IMPLANTED IN THE MID TO DISTAL RIGHT CORONARY ARTERY. A 2.00MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED BUT HAD DIFFICULTY IN CROSSING THE PREVIOUSLY IMPLANTED STENT. THE BALLOON CATHETER EVENTUALLY CROSSED THE PREVIOUSLY DEPLOYED STENT HOWEVER THE BALLOON RUPTURED AT AN UNKNOWN ATMOSPHERE AND AT AN UNKNOWN NUMBER OF INFLATION. THE PROCEDURE WAS COMPLETED USING A 2.0MM NON BSC BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357331 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493919315200 15786559

    Patients

    Seq Age Sex Outcome Treatment
    1