BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 2231408 · Received September 1, 2011

    Report

    Report Number
    3005099803-2011-02903
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HTA PROCEDURE SET WAS RETURNED AND EVALUATED. THE DISPOSABLE HEATER CANISTER FOUND THAT THE TOP 2/3 OF THE CYLINDER WAS CRYSTALLIZED, THE HEATING ROD IS DISCOLORED, AND THE TOP CONNECTOR HOUSING IS DEFORMED AND CRYSTALLIZED. A REVIEW OF ALL AVAILABLE INFORMATION FAILED TO INDICATE A PROBABLE ROOT CAUSE OF THE EVENT AS THERE ARE MULTIPLE CAUSES FOR THE HEATER CANISTER OVERHEATING. THE ROOT CAUSE OF THE EVENT IS THEREFORE UNDETERMINABLE.

    Additional Manufacturer Narrative · 1

    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 INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A HYDRO THERMABLATOR PROCERVA PROCEDURE SET WAS USED DURING A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6), 2011. (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE COIL WITHIN THE HEATER CANISTER OVERHEATED AND GLOWED ORANGE. ADDITIONAL FOLLOW UP INFORMATION FROM THE CLINICIAN CONFIRMED THAT THE COIL WITHIN THE HEATER CANISTER OVERHEATED. IN ADDITION, THE HEATER CANISTER ALSO MELTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE CONDITION OF THE PATIENT IS REPORTED TO BE "FINE."

    Description of Event or Problem · 1

    A HYDRO THERMABLATOR PROCERVA PROCEDURE SET WAS USED DURING A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6), 2011. (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE COIL WITHIN THE HEATER CANISTER OVERHEATED AND GLOWED ORANGE. ADDITIONAL FOLLOW UP INFORMATION FROM THE CLINICIAN CONFIRMED THAT THE COIL WITHIN THE HEATER CANISTER OVERHEATED. IN ADDITION, THE HEATER CANISTER ALSO MELTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE 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 M006560211 0000040560

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR