BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX FLEX MONORAIL

    MDR report key: 1133091 · Received August 22, 2008

    Report

    Report Number
    2134265-2008-02417
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 24, 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 BALLOON CATHETER WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE BALLOON CATHETER COULD NOT BE COMPLETED. 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 99% STENOTIC, DE NOVO AND CALCIFIED LESION WAS LOCATED IN THE MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. VASCULAR ACCESS WAS GAINED THROUGH BRACHIAL ARTERY. UPON ATTEMPTING TO ADVANCE THE APEX FLEX MONORAIL 1.5 X 15MM BALLOON CATHETER TO THE LESION FOR PRE-DILATATION, RESISTANCE WAS ENCOUNTERED AND THE CATHETER WAS UNABLE TO CROSS THE LESION COMPLETELY. HOWEVER, SINCE THE BALLOON PARTIALLY CROSSED THE LESION, THE PHYSICIAN INFLATED THE BALLOON. THE BALLOON RUPTURED AT 6ATMS ON THE 1ST INFLATION. IT WAS REPORTED THAT ACCORDING TO THE PHYSICIAN, THE BALLOON RUPTURE MIGHT HAVE BEEN CAUSED BY THE CALCIFIED LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND A COMPETITOR STENT WAS IMPLANTED. THERE WERE NO PT INJURIES OR COMPLICATIONS. THE PT'S STATUS WAS REPORTED AS "GOOD." THIS PRODUCT IS ONLY OUS APPROVED, BUT IT IS SIMILAR TO A MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX FLEX MONORAIL NA LOX BOSTON SCIENTIFIC 1.5X15 MM 11263506

    Patients

    Seq Age Sex Outcome Treatment
    1 CYPHER 2.5X28 STENT| SPRINTER 1.5X15 BALLOON CATHETER| RUNTHROUGH GUIDE WIRE| EVEREST| HIRYU 2.5X20 BALLOON CATHETER| LAUNCHER JL3.5 GUIDE CATHETER| TERUMO INTRODUCER SHEATH