BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 1171331 · Received September 17, 2008

    Report

    Report Number
    2134265-2008-02669
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 29, 2008
    Report Date
    August 29, 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 COMPLAINT DEVICE WAS NOT RETURNED, THEREFORE PRODUCT ANALYSIS WAS NOT POSSIBLE. WITHOUT A RETURNED DEVICE, IT WAS NOT POSSIBLE TO CONFIRM THE REPORTED EVENT, AND INSPECT THE DEVICE FOR POSSIBLE ROOT CAUSES. THE MANUFACTURING RECORDS WERE REVIEWED, AND NO ISSUES OR DISCREPANCIES OCCURRED DURING PRODUCTION OF THIS BATCH THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS RECORDS REVIEW INDICATES THAT THE DEVICE MET SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT CAN BE ATTRIBUTED TO OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE 2.0X20MM APEX MONORAIL BALLOON WAS ADVANCED TO THE TARGET LESION AND WAS INFLATED TO 12ATMS ON THE FIRST AND SECOND INFLATIONS. THE BALLOON WAS INFLATED A THIRD TIME TO 12 ATMS AND RUPTURED AFTER 3-4 SECONDS. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A 2.25X20MM NON BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "GOOD". 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 MONORAIL NA LOX BOSTON SCIENTIFIC 2.0X20MM 9696016

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR BC: POWERED LACROSSE 2.25X20| GC: 6FR LAUNCHER SL4| GW: RUNTHROUGH FLOPPY| STENT: CYPHER 2.5X18