BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE¿

    MDR report key: 2994122 · Received March 8, 2013

    Report

    Report Number
    2134265-2013-01350
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE VASCULAR ACCESS SITE WAS RADIAL. THE LESION WAS MODERATELY TO SEVERELY CALCIFIED. THE BALLOON WAS USED FOR PREDILATATION. THE EMERGE, MR, OUS 8MM X 1.20MM RUPTURED AT EIGHTEEN ATMOSPHERES ON THE FIRST INFLATION. THE DEVICE WAS REMOVED INTACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 99% STENOSED LESION WAS LOCATED IN A NON CALCIFIED AND MODERATELY TORTUOUS RIGHT CORONARY ARTERY. THE EMERGE, MR, OUS 8MM X 1.20MM WAS INFLATED AND RUPTURED AT EIGHTEEN ATMOSPHERES. THE NUMBER OF INFLATIONS IS UNKNOWN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100024 EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493919308120 15709678

    Patients

    Seq Age Sex Outcome Treatment
    1