BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 1952495 · Received January 7, 2011

    Report

    Report Number
    3005099803-2010-05414
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EMPTY SHEATH PACKAGING WAS RETURNED AND THE LABEL TOP WAS REMOVED FROM THE PACKAGING. NO FOREIGN OBJECTS WERE OBSERVED IN THE PACKAGING PRE AND POST DISINFECTION. THERE WAS NO OTHER VISIBLE DAMAGE OBSERVED ON THE PACKAGING. ALTHOUGH THE LABEL TOP WAS REMOVED FROM THE SHEATH PACKAGING, THIS WAS NOT A FAILURE OF STERILITY AS THE CUSTOMER STATED THEY HAD OPENED THE PACKAGING. THE COMPLAINT EVENT WAS NOT CONFIRMED. THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS "SUPPLIER MANUFACTURE".

    Additional Manufacturer Narrative · 1

    THE OUTER PACKAGING WAS RETURNED ON (B)(6) 2010 BUT THERE WAS NO HAIR CONTAINED IN THE PACKAGING. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT HAS BEEN DISPOSED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THIS EVENT. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS BEING PREPARED FOR A HYDROTHERMABLATION (HTA) PROCEDURE (PATIENT'S INITIALS, AGE OR BIRTH DATE AND WEIGHT ARE NOT KNOWN) ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE KIT WAS OPENED AND WAS REPORTED TO HAVE A HAIR INSIDE THE PACKAGING. NO VISIBLE DAMAGE WAS NOTICED TO THE PACKAGING AND THE SEAL OF THE PACKAGING WAS NOT COMPROMISED. ANOTHER OF THE SAME DEVICE WAS USED FOR THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE".

    Description of Event or Problem · 1

    A HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS BEING PREPARED FOR A HYDROTHERMABLATION (HTA) PROCEDURE (PATIENT'S INITIALS, AGE OR BIRTH DATE AND WEIGHT ARE NOT KNOWN) ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE KIT WAS OPENED AND WAS REPORTED TO HAVE A HAIR INSIDE THE PACKAGING. NO VISIBLE DAMAGE WAS NOTICED TO THE PACKAGING AND THE SEAL OF THE PACKAGING WAS NOT COMPROMISED. ANOTHER OF THE SAME DEVICE WAS USED FOR THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AND 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 M006560211 0000040352

    Patients

    Seq Age Sex Outcome Treatment
    1