BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIPHERAL CUTTING BALLOON

    MDR report key: 1162197 · Received September 16, 2008

    Report

    Report Number
    2134265-2008-02664
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 21, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    PMA / PMN Number
    K041993
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, CUTTING BALLOON BLADE DETACHMENT OCCURRED. THE SEVERELY CALCIFIED LESION WAS LOCATED IN THE BASILIC VEIN. THE PERIPHERAL 8.00MM X 2.0CM X 135CM CUTTING BALLOON WAS ADVANCED TO THE LESION AND INFLATED ONCE TO 8ATMS. UPON REMOVAL OF THE CUTTING BALLOON FROM THE PATIENT'S BODY, THE PHYSICIAN NOTED THAT THE BLADES WERE HANGING OFF OF THE BALLOON. THE DEVICE WAS REMOVED AS A UNIT FROM THE PATIENT WITHOUT FURTHER INTERVENTION. THE PROCEDURE WAS COMPETED SUCCESSFULLY WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT INJURIES OR COMPLICATIONS. THE PATIENT'S STATUS WAS REPORTED AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIPHERAL CUTTING BALLOON LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC NA EH5670

    Patients

    Seq Age Sex Outcome Treatment
    1 MERIT INFLATION DEVICE