BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX FLEX OVER-THE-WIRE

    MDR report key: 1060053 · Received June 11, 2008

    Report

    Report Number
    2134265-2008-01659
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPETED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, CATHETER REMOVAL DIFFICULTIES OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PHYSICIAN DILATED THE LESION WITH A 1.5X20MM APEX FLEX OVER-THE-WIRE BALLOON THREE TIMES TO 10ATMS. THE PHYSICIAN THEN ATTEMPTED TO EXCHANGE THE BALLOON BY USING THE 'NANTO TECHNIQUE" WHICH WAS REPORTED TO BE AN OVER-THE-WIRE BALLOON EXCHANGE METHOD WITH A REGULAR-LENGTH GUIDE WIRE, BUT THE BALLOON WAS UNABLE TO BE REMOVED OUTSIDE THE PATIENT'S BODY. THE PHYSICIAN THEN REMOVED THE APEX DEVICE ALONG WITH THE GUIDE WIRE AND IT WAS NOTED THAT THE PHYSICIAN FELT RESISTANCE. IT WAS NOTED THAT THE PHYSICIAN DID NOT EXPERIENCE ANY DEFLATION DIFFICULTIES AND THE BALLOON WAS FULLY DEFLATED AND INTACT WHEN IT WAS REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED. THIS PRODUCT IS ONLY OUS APPROVED, BUT IS SIMILAR TO A MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX FLEX OVER-THE-WIRE NA LOX BOSTON SCIENTIFIC 1.5X20MM 11092452

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR