BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESYS HTA PROCERVA®

    MDR report key: 3972822 · Received August 1, 2014

    Report

    Report Number
    3005099803-2014-02717
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    June 20, 2014
    Report Date
    July 11, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS NOT KNOWN PER THE COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED, HOWEVER, IT WAS REPORTED THAT THE DEVICE WAS NOT USED PAST EXPIRY DATE. 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 USED IN A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6), 2014. ACCORDING TO THE COMPLAINANT, DURING HYSTEROSCOPY, A PERFORATION WAS OBSERVED ON THE UTERUS. IT IS NOT CONFIRMED AS TO WHAT EXACTLY CAUSED THE INJURY. NO ANATOMICAL ISSUES WERE NOTED AND THE PATIENT WAS NOT CRAMPING. THE PERFORATION WAS ALLOWED TO HEAL NATURALLY AND DID NOT REQUIRE ANY TREATMENT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND THE PATIENT WAS RESCHEDULED FOR ANOTHER HTA PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450811 GENESYS HTA PROCERVA® DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - SPENCER M006580211

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other