BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYRDOTHERMABLATOR PROCEDURE SET

    MDR report key: 1051086 · Received May 22, 2008

    Report

    Report Number
    3005099803-2008-00521
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 25, 2008
    Report Date
    April 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NO BE RETURNED FOR EVALUATION SINCE IT WAS DISPOSED OF; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. TWO POSSIBLE LOTS HAVE BEEN IDENTIFIED FOR THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THESE LOTS; NO EVIDENCE OF A MANUFACTURING RELATED, POTENTIAL CAUSE FOR THIS TYPE OF EVENT WAS FOUND. A SEARCH OF THE COMPLAINT DATABASE FOR SIMILAR COMPLAINTS WAS CONDUCTED, NO SIMILAR COMPLAINTS HAVE BEEN RECORDED FOR THESE LOTS. THE HTA USER'S MANUAL INDICATES THAT THE INDICATION FOR USE OF HTA IS TO ABLATE THE ENDOMETRIAL LINING OF THE UTERUS IN PREMENOPAUSAL WOMEN WITH MENORRHAGIA (EXCESSIVE UTERINE BLEEDING) DUE TO BENIGN CAUSES FOR WHOM CHILDBEARING IS COMPLETE. THE BLEEDING AND CLOTTING DESCRIBED IN THE EVENT DESCRIPTION APPEARS CONSISTENT WITH SOMEONE WHO HAS MENORRHAGIA.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FEMALE PATIENT (WEIGHT UNKNOWN) UNDERWENT A THERAPEUTIC HYDROTHERMAL ABLATION PROCEDURE IN 2008. ACCORDING TO COMPLAINANT, DURING THE HYSTEROSCOPY PHASE, THE PROCEDURE SET BECAME CLOGGED WITH EXCESSIVE TISSUE. THE PHYSICIAN CLEARED THE TUBING AND NOTICED A 5 CM BLOOD CLOT. THEY RESTARTED THE SYSTEM BUT THE PROCEDURE SET BECAME CLOGGED AGAIN. THEY CLEARED THE LINE AND NOTICED ANOTHER BLOOD CLOT APPROXIMATELY 3 CM IN SIZE. THE PHYSICIAN PROCEED WITH THE PROCEDURE. DURING THE END OF THE WARMING PHASE, VISUALIZATION WORSENED AND FLUID LEVELS WENT UP DUE TO THE PATIENT BLEEDING HEAVILY. THE FLUID IN THE RESERVOIR TURNED DARK RED AND STARTED TO FILL UP. APPROXIMATELY TWO MINUTES INTO THE PROCEDURE THERE WAS AN EXCESSIVE FLUID ALARM. THE PROCEDURE SET TUBING WAS CHECKED FOR KINKS AND CLEARED AGAIN. THE PHYSICIAN DECIDED TO ABORT THE CASE AND WENT INTO THE COOL DOWN PHASE AFTER ONLY 1-2 MINUTES OF ABLATION. THE PHYSICIAN OPTED TO PERFORM A HYSTEROSCOPY WITHOUT THE HTA PROCEDURE. DURING THE HYSTEROSCOPY, THE PATIENT WAS STILL BLEEDING HEAVILY. REPORTEDLY, THE PHYSICIAN NOTED THE TISSUE LOOKED ODD, SORT OF A "POWDERY CONSISTENCY". THE PHYSICIAN WAS NOT CONCERNED ABOUT TISSUE. HE HAD PATHOLOGY EXAMINE THE SUBSTANCE AND EVERYTHING LOOKED "FINE". THE PHYSICIAN STATED THAT THE PATIENT IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other