BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX FLEX MONORAIL

    MDR report key: 1022280 · Received March 26, 2008

    Report

    Report Number
    2134265-2008-00884
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 5, 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 AN ANALYSIS OF THE COMPLAINT DEVICE, IT WAS NOT POSSIBLE TO DETERMINE IF ANY DEVICE ANOMALIES EXISTED THAT MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED, BUT IT IS NOTABLE THAT THE LESION BEING TREATED WAS 90% STENOSED WITH CALCIFICATION. THE ROOT CAUSE WILL BE DOCUMENTED AS OPERATIONAL CONTEXT BECAUSE OF THE LIKELIHOOD THAT THE PT ANATOMY CONTRIBUTED TO THE REPORTED EVENT. THE MFG RECORDS WERE REVIEWED AND NO ISSUE OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS PRIOR TO SHIPMENT.

    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 MODERATELY TORTUOUS AND CALCIFIED MID RIGHT CORONARY ARTERY (RCA). THE 1.50X8MM APEX FLEX MONORAIL BALLOON CATHETER WAS INFLATED TO 6 ATMS FOR FIVE SECONDS IN THE RCA WHEN THE BALLOON GOT A "PINHOLE RUPTURE". THE BALLOON WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PT COMPLICATIONS WERE REPORTED WITH THE PT'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 FLEX MONORAIL PTCA DILATATION CATHETER LOX BOSTON SCIENTIFIC 1.50X8MM 11344130

    Patients

    Seq Age Sex Outcome Treatment
    1