BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROTHERMABLATOR PROCEDURE SET

    MDR report key: 1062027 · Received June 13, 2008

    Report

    Report Number
    3005099803-2008-00721
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (UNK, FOR USE WHEN THE DEVICE PROBLEM IS NOT KNOWN) - NOT LABELED. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; SINCE IT WAS DISPOSED OF AND THEREFORE A FAILURE ANALYSIS IS NOT AVAILABLE. WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. THE COMPLAINT ALLEGES MULTIPLE FLUID LOSS ALARMS DUE TO THE POSSIBLE SHEATH PUNCTURE. A DHR REVIEW DID NOT YIELD ANY MANUFACTURING RELATED ISSUES WHICH WOULD CONTRIBUTE TO THIS EVENT. A REVIEW OF THE TRENDING, HISTORY AND THE EVENT DESCRIPTION DID NOT PROVIDE ENOUGH INFO TO FORMULATE A DEFINITIVE ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PT UNDERWENT A THERAPEUTIC HYDROTHERMAL ABLATION (HTA) PROCEDURE THAT OCCURRED IN 2008. DURING THE HEATING PHASE, A FLUID LOSS ALARM WAS GENERATED OF 16CC'S PER MINUTE. THE PHYSICIAN EXAMINED THE PT AND DID NOT NOTICE ANY SIGNS OF FLUID LOSS. THE PHYSICIAN ADDED A SECOND TENACULUM STABILIZER IN ORDER TO MAINTAIN A GOOD CERVICAL SEAL AND CONTINUED WITH THE PROCEDURE. APPROXIMATELY ONE MINUTE INTO THE ABLATION PHASE A FLUID LOSS ALARM OF 3CC'S PER MINUTE OCCURRED. THE PHYSICIAN INSPECTED THE CERVIX AGAIN AND DID NOT SEE ANY FLUID IN CAVITY (VAGINA) AND CONTINUED. THE PHYSICIAN CONTINUED WITH THE CASE BUT IMMEDIATELY ANOTHER FLUID LOSS ALARM OF 80CC'S PER MINUTE. THE CASE WAS ABORTED AND UPON VISUAL INSPECTION NO SIGN OF ANY FLUID LOSS OR PERFORATIONS OR VAGINAL BURNS. THE PHYSICIAN DECIDED TO PLACE AN ENDO LOOP TO SEAL CERVIX. THE PROCEDURE SET WAS REPLACED WITH A NEW ONE AND THE CASE WAS COMPLETED SUCCESSFULLY WITH NO PT COMPLICATIONS. IT IS BELIEVED THAT THERE COULD HAVE BEEN A PUNCTURE IN THE SHEATH DUE TO THE MULTIPLE TENACULUM STABILIZERS BEING ADDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROTHERMABLATOR PROCEDURE SET MNB BOSTON SCIENTIFIC CORPORATION M006560201 0000033978

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK