BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX DILATATION BALLOON

    MDR report key: 1160032 · Received September 12, 2008

    Report

    Report Number
    3005099803-2008-04509
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K833417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED A KINK ON THE CATHETER SHAFT 5MM PROXIMAL TO THE BALLOON. A FUNCTIONAL EVALUATION FOUND THE CATHETER SHAFT LEAKING CLOSE TO THE PROXIMAL BOND WHEN BALLOON INFLATION WAS ATTEMPTED. THE CAUSE OF THE REPORTED MALFUNCTION IS LIKELY ATTRIBUTABLE TO OPERATIONAL CONTEXT, DUE TO INADVERTENT DAMAGE DURING INSERTION OF THE SHAFT THROUGH THE SCOPE. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PATIENT LOT WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY SIMILAR COMPLAINTS FOR THE REPORTED LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT AN RX DILATATION BALLOON DEVICE WAS USED ON THE DAY BEFORE (A MALE PATIENT; WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS INSERTED OVER THE GUIDEWIRE TO THE TARGETED LESION, THEN WATER WAS INJECTED INTO THE DEVICE TO EXPAND IT. WATER WAS OBSERVED LEAKING FROM THE DISTAL TIP OF THE CATHETER SHAFT APPROXIMATELY 4MM FROM THE BODY OF THE BALLOON. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER RX DILATATION BALLOON DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AS THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX DILATATION BALLOON KOG BOSTON SCIENTIFIC CORPORATION M00545940 0011641254

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR