BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE¿

    MDR report key: 2972274 · Received February 21, 2013

    Report

    Report Number
    2134265-2013-00854
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 27, 2013
    Report Date
    January 28, 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). THE COMPLAINT DEVICE WAS NOT RETURNED 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 OF THE TARGET LESION WAS VIA THE RADIAL ARTERY. THE TARGET LESION WAS SEVERELY CALCIFIED AND THE 15MM X 1.50MM EMERGE MR BALLOON RUPTURED UPON THE 1ST INFLATION. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND MODERATELY TORTUOUS DISTAL RIGHT CORONARY ARTERY. THIS 15MM X 1.50MM EMERGE MR BALLOON CATHETER WAS SELECTED FOR PRE-DILATATION. THE BALLOON WAS INFLATED AND RUPTURED AT 6ATM. THE PROCEDURE WAS CONTINUED 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
    75596 EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493919315150 15655553

    Patients

    Seq Age Sex Outcome Treatment
    1