BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROTHERMABLATOR PROCEDURE SET

    MDR report key: 1080961 · Received July 23, 2008

    Report

    Report Number
    3005099803-2008-01249
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 19, 2008
    Report Date
    June 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE USED IS UNK, CONSEQUENTLY THE DEVICE MANUFACTURING AND EXP DATES ARE UNK. A PRODUCT ANALYSIS COULD NOT BE PERFORMED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVAL; AS IT WAS DISPOSED OF AT THE USER FACILITY. A SHIP HISTORY WAS PERFORMED AND RESULTED IN TWO PROBABLE BATCHES. A DEVICE HISTORY REVIEW (DHR) DID NOT YIELD ANY MANUFACTURING RELATED CAUSE FOR THE REPORTED INCIDENT. THE DFU STATES THAT PT THERMAL INJURIES ARE A POTENTIAL ADVERSE EVENT ASSOCIATED WITH HTA PROCEDURES, AND STRESSES THE IMPORTANCE OF MAINTAINING AND OBSERVING THE CERVICAL SEAL IN ORDER TO REDUCE THE POTENTIAL OF PT THERMAL INJURIES. BASED ON GATHERED INFO, IT CAN BE CONSIDERED THAT THIS EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT DURING A THERAPEUTIC HYDROTHERMAL ABLATION (HTA) PROCEDURE A CERVICAL BURN WAS OBSERVED IN THE PT. THE PT FELT HOT SALINE IN HER VAGINA, 7 1/2 TO 8 MINUTES INTO THE PROCEDURE, THE HYDROTHERMABLATOR PROCEDURE SET DID NOT ALARM. THE PHYSICIAN PRESSED STOP ON THE MACHINE, AND QUICKLY EXTRACTED THE 4 BY 4 GAUZE PADS TO SOAK UP THE HOT SALINE (PHYSICIAN FELT APPROX 3-5 CCS). HE ABORTED THE PROCEDURE AND NOTICED THAT THE PT HAD A CM BY CM BLANCHING ON HER CERVIX. THE BURN WAS TREATED WITH ANTIBIOTICS. THE PHYSICIAN STATED IT WAS A SECOND DEGREE BURN. THE PHYSICIAN FOLLOWED UP 4 DAYS LATER AND STATED THE PT IS HEALING WELL AND INTENDS TO FOLLOW UP AGAIN, IN THREE DAYS.

    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