BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 2040509 · Received April 6, 2011

    Report

    Report Number
    3005099803-2011-01076
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS NOT KNOWN PER THE COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS DISPOSED OF AND IS NOT AVAILABLE FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE SECOND OF TWO DEVICES USED IN THE SAME PROCEDURE. REFER TO THE ASSOCIATED MANUFACTURER REPORT NUMBER 3005099803-2011-01077 FOR A DESCRIPTION OF THE FIRST DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED IN A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6) 2011 (PATIENT ID, AGE, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, TWO 10CC FLUID LOSS ALARMS WERE RECEIVED DURING THE HEATING PHASE. THE PROCEDURE SET AND SHEATH WERE CHANGED OUT, AND THE NURSE OBSERVED THE SHEATH HAD BEEN PUNCTURED BY THE TENACULUM. IT WAS CONFIRMED THAT THE PUNCTURE WAS DUE TO OPERATOR ERROR, AND THE FLUID WAS NEVER HEATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT PROCEDURE SET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - MARLBOROUGH UNK560

    Patients

    Seq Age Sex Outcome Treatment
    1