BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PTCA CATHETER

    MDR report key: 1133738 · Received August 20, 2008

    Report

    Report Number
    2134265-2008-02409
    Event Type
    Malfunction
    Date Received
    August 20, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS FOUND THAT THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BALLOON IDENTIFIED A PINHOLE LEAK IN THE MIDDLE OF THE BALLOON. THE RETURNED DEVICE WAS CONNECTED TO AN INFLATION UNIT IN AN ATTEMPT TO INFLATE WATER INTO THE BALLOON AND IDENTIFY IF ANY LEAKS WERE PRESENT. THE INFLATION DEVICE WAS SLOWLY INFLATED TO THE NOMINAL PRESSURE OF 8 ATMOSPHERES (ATM) AND A PINHOLE LEAK WAS IDENTIFIED. SOLIDIFIED BLOOD WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE, INDICATING THE DEVICE HAD BEEN USED IN VIVO. THERE WERE SEVERE KINKS ALONG THE ENTIRE LENGTH OF THE HYPOTUBE. A RECOMMENDED SIZED PRODUCT MANDREL (0.015 INCH) WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. A REVIEW OF THE MANUFACTURING RECORDS FOUND THAT THE DEVICE MET MATERIAL, ASSEMBLY AND PRODUCT 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

    SAME CASE AS #2134265-2008-02410. IT WAS REPORTED THAT DURING A CARDIAC CATHETERIZATION PROCEDURE, TWO BALLOON RUPTURES OCCURRED. THE LESION WAS LOCATED IN A SEVERELY CALCIFIED VESSEL. A 3.5X15MM NC MONORAIL BALLOON WAS USED AND RUPTURED AT NOMINAL PSI. ANOTHER 3.5X15MM NC MONORAIL BALLOON WAS USED WHICH ALSO RUPTURED AT NOMINAL PSI. THE PROCEDURE WAS COMPLETED WITH ANOTHER NC MONORAIL BALLOON. NO PATIENT COMPLICATIONS OCCURRED. PATIENT STATUS IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC NCM 15/3.5 0008961779

    Patients

    Seq Age Sex Outcome Treatment
    1