BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESYS HTA PROCERVA®

    MDR report key: 3131705 · Received May 29, 2013

    Report

    Report Number
    3005099803-2013-04390
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GENESYS HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS BEING PREPPED FOR USE IN A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, A PINHOLE WAS NOTED TO THE INNER PACKAGING OF THE STERILE KIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SECOND GENESYS PROCEDURE SET. THE PATIENT WAS REPORTED TO BE FINE AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234282 GENESYS HTA PROCERVA® DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - MARLBOROUGH M006580211

    Patients

    Seq Age Sex Outcome Treatment
    1