BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 2031599 · Received March 28, 2011

    Report

    Report Number
    3005099803-2011-00940
    Event Type
    Malfunction
    Date Received
    March 28, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH EXPECTED, THE DEVICE AT ISSUE IN THIS COMPLAINT HAS NOT YET BEEN RECEIVED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE. 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.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE COMPLAINT EVALUATION WAS COMPLETED AND THE REPORTED ISSUE(S) COULD NOT BE DUPLICATED. HTA LOGIC/WET TEST WAS PERFORMED, AND THE UNIT DID NOT SKIP ANY STEPS.

    Description of Event or Problem · 1

    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, THE NURSE SET UP THE SYSTEM AND PRESSED START ONCE. AT THAT TIME, THE CONSOLE QUICKLY ADVANCED TO THE FILLING STAGE. THE NURSE SHUT DOWN THE SYSTEM AND ATTEMPTED TO RE-START. THE SAME PROBLEM OCCURRED TWO MORE TIMES. THE PROCEDURE WAS ABORTED. THE PHYSICIAN AND PATIENT WERE NOT IN THE ROOM NOR IN ROUTE. 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."

    Description of Event or Problem · 1

    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, THE NURSE SET UP THE SYSTEM AND PRESSED START ONCE. AT THAT TIME, THE CONSOLE QUICKLY ADVANCED TO THE FILLING STAGE. THE NURSE SHUT DOWN THE SYSTEM AND ATTEMPTED TO RE-START. THE SAME PROBLEM OCCURRED TWO MORE TIMES. THE PROCEDURE WAS ABORTED. THE PHYSICIAN AND PATIENT WERE NOT IN THE ROOM NOR IN ROUTE. 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 M00656000R0

    Patients

    Seq Age Sex Outcome Treatment
    1