BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX OVER-THE-WIRE

    MDR report key: 1900131 · Received November 16, 2010

    Report

    Report Number
    2134265-2010-04986
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 23, 2010
    Report Date
    October 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, AS BALLOON RUPTURE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN AN UNSPECIFIED VESSEL. THE PHYSICIAN ADVANCED THE 2.0X15MM APEX BALLOON TO THE LESION AND THE BALLOON RUPTURED UNDER NOMINAL PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.0X15MM APEX BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX OVER-THE-WIRE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493895815200 13568268

    Patients

    Seq Age Sex Outcome Treatment
    1