BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROTHERMABLATOR PROCEDURE SET

    MDR report key: 1202849 · Received October 17, 2008

    Report

    Report Number
    3005099803-2008-05329
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE USED IS UNK, CONSEQUENTLY THE DEVICE MFG AND EXPIRATION DATES ARE UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT DURING AN HTA PROCEDURE, A PT WAS OBSERVED TO HAVE A BURN FOLLOWING A FLUID LEAK FROM THE HYDROTHERMABLATOR PROCEDURE SET. THE PHYSICIAN REPORTED THAT 9 MINUTES AND 15 SECONDS INTO ABLATION, PART OF THE SUPERIOR PORTION OF THE SHEATH CRACKED (NEAR WHERE THE PHYSICIAN HOLDS IT AND WHERE THE ADAPTER SCREWS ON). THE FLUID LOSS ALARM SOUNDED AFTER THE BREAK AND FLUID LEAKING OUT (RATE OF LOSS 150 CC PER MINUTE). THE PHYSICIAN COMPLETED THE PROCEDURE USING HIS HAND TO HOLD IN THE LEAK FOR THE REMAINING 45 SECONDS. A SECOND DEGREE BURN WAS OBSERVED BY THE PHYSICIAN, THE BURN WAS APPROX 2 CENTIMETERS LONG, DOWN THE CENTER OF THE BUTTOCKS ON BOTH CHEEKS. THERE WAS NO VAGINAL BURN. PT WAS TREATED IMMEDIATELY, BUT WHAT WAS USED TO TREAT THE BURN IS UNK. PT IS IMPROVING AND ACCORDING TO THE PHYSICIAN WILL RECOVER COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROTHERMABLATOR PROCEDURE SET MNB BOSTON SCIENTIFIC CORPORATION M006560201 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other