BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX DILATATION BALLOON

    MDR report key: 1191210 · Received September 26, 2008

    Report

    Report Number
    3005099803-2008-04888
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K833417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNK. THE SUSPECT DEVICE HAS BEEN RETURNED, HOWEVER, THE DEVICE EVALUATION IS NOT COMPLETE. THE CAUSE OF THE BALLOON RUPTURE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008 THAT AN RX DILATATION BALLOON WAS USED DURING A DILATATION PROCEDURE THE DAY PRIOR. ACCORDING TO THE COMPLAINANT, "THE BALLOON WAS RUPTURED DURING INFLATING UP TO 8 ATMS... SINCE THE LESION WAS FULLY INFLATED PRIOR TO THE INCIDENT" (IE, THE PROCEDURE WAS COMPLETE), THE EVENT DID NOT AFFECT THE OUTCOME OF THE PROCEDURE. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK