BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESYS HTA PROCERVA®

    MDR report key: 3070996 · Received April 22, 2013

    Report

    Report Number
    3005099803-2013-02591
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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) 2013. ACCORDING TO THE COMPLAINANT, WITH FOUR MINUTES LEFT TO GO IN THE ABLATION PHASE OF THE PROCEDURE THE SITE RECEIVED A FLUID LOSS ALARM. PRIOR TO THE FLUID LOSS, THE DOCTOR HAD BEEN HOLDING THE SHEATH AT A 45 DEGREE ANGLE LATERALLY TO ACCOMMODATE THE PATIENT'S BI-CORNUATE UTERUS. THE PATIENT, WHO WAS UNDER MONITORED ANESTHESIA CARE (MAC), MOVED SLIGHTLY JUST BEFORE THE FLUID LOSS ALARM. THERE WAS NO CERVICAL LEAK NOTED AND THE PROCEDURE WAS COMPLETED WITH THE SAME PROCEDURE SET WITHOUT FURTHER FLUID LOSS ALARMS. POST PROCEDURE, THE DOCTOR NOTICED A SMALL BURN JUST INSIDE THE PATIENT'S VAGINAL CANAL LEAD HER TO SUSPECT A CERVICAL LEAK. AN ADDITIONAL ATTEMPT HAS BEEN MADE TO OBTAIN FOLLOW UP EVENT DETAILS WITH NO RESPONSE FROM THE CLINICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171265 GENESYS HTA PROCERVA® DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - MARLBOROUGH M006580211

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR