BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK OVER-THE-WIRE PTCA CATHETER

    MDR report key: 1221534 · Received November 5, 2008

    Report

    Report Number
    2134265-2008-04227
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P030025
    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 CONFIRM THE REPORTED EVENT AND INSPECT THE DEVICE FOR POSSIBLE ROOT CAUSES. THERE WAS NO INDICATION OF A MANUFACTURING DEFECT OR ANOMALY IDENTIFIED WITHIN THE REVIEW OF THE MANUFACTURING RECORDS FOR THE REPORTED BATCH #. THE MANUFACTURING RECORDS HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THIS COMPLAINT IS OPERATIONAL CONTEXT, DUE TO THE LIKELIHOOD OF ANATOMICAL AND OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS INTERVENTION, A BALLOON RUPTURE OCCURRED. THE LESION WAS LOCATED IN A SEVERELY CALCIFIED AND SEVERELY TORTUOUS PROXIMAL CIRCUMFLEX ARTERY. A 1.5X15MM MAVERICK BALLOON WAS INFLATED AND RUPTURED AT 10 ATM'S. THE PROCEDURE WAS COMPLETED WITH ANOTHER MAVERICK BALLOON. NO PT COMPLICATIONS OCCURRED. PT STATUS IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK OVER-THE-WIRE PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC 15/1.5 8635840

    Patients

    Seq Age Sex Outcome Treatment
    1