BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 2033389 · Received March 30, 2011

    Report

    Report Number
    3005099803-2011-00958
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HTA PROCEDURE SET WAS RETURNED AND EVALUATED. VISUAL EXAMINATION OF THE DISPOSABLE HEATER CANISTER CONFIRMED THE EVENT. THE CYLINDER WAS CRYSTALIZED 360° AROUND FOR 3/4 OF THE ENTIRE LENGTH. THE PLASTIC THERMISTER HOUSING WAS ALSO CRYSTALIZED. THE ROOT CAUSE CLASSIFICATION FOR THIS EVENT IS UNDETERMINABLE, BASED ON THE RETURNED CONDITION OF THE PRODUCT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, EXPIRATION AND MANUFACTURING DATES CANNOT BE DETERMINED. ALTHOUGH THE PRODUCT HAS BEEN RETURNED, THE DEVICE HAS NOT YET BEEN EVALUATED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THIS EVENT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED DURING A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6), 2011. (PATIENT ID, AGE, DATE OF BIRTH AND WEIGHT ARE UNKNOWN).ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE HEATER CANISTER OVERHEATED AND MELTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED WITH THIS EVENT AND THE CURRENT CONDITION OF THE PATIENT IS REPORTED TO BE "FINE."

    Description of Event or Problem · 1

    A HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED DURING A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6), 2011. (PATIENT ID, AGE, DATE OF BIRTH AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE HEATER CANISTER OVERHEATED AND MELTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED WITH THIS EVENT AND THE CURRENT CONDITION OF THE PATIENT IS 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 M006560210

    Patients

    Seq Age Sex Outcome Treatment
    1