BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROTHERMABLATOR PROCEDURE SET

    MDR report key: 1133209 · Received August 22, 2008

    Report

    Report Number
    3005099803-2008-03627
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    June 18, 2008
    Report Date
    July 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; AS IT WAS DISPOSED OF, THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE. WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A PT UNDERWENT A THERAPEUTIC HYDROTHERMAL ABLATION (HTA) PROCEDURE THAT OCCURRED IN 2008. ACCORDING TO THE COMPLAINANT, APPROX FIVE MINUTES INTO THE ABLATION STAGE A FLUID LOSS ALARM OCCURRED WITH A RATE OF 10 CC PER MINUTE. THE PT COMPLAINED OF FEELING A BURNING SENSATION, THE PHYSICIAN THEN REMOVED THE SHEATH PREMATURELY. A BOSTON SCIENTIFIC REP, WHO WAS PRESENT DURING THE PROCEDURE, INSTRUCTED THE STAFF TO PUT SALINE INTO THE VAGINA. THE PHYSICIAN EXAMINED THE PT AND DID NOT NOTE ANY BURNS. POST PROCEDURE ON THE FOLLOWING MONTH, THE PT CONTACTED THE PHYSICIAN'S OFFICE COMPLAINING OF DISCOMFORT. THE PHYSICIAN PERFORMED AN EXAM AND NOTED A 3RD DEGREE CERVICAL BURN. THE PT'S BURN WAS TREATED WITH CLINDOMIYCIN AND METROGEL. THE PT'S CONDITION IS REPORTED AS FINE.

    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 Required Intervention