BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESYS HTA PROCERVA®

    MDR report key: 4093806 · Received September 16, 2014

    Report

    Report Number
    3005099803-2014-03132
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH 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 THE HEATING UP PHASE OF THE PROCEDURE, A SECOND TENACULUM WAS ADDED INTO THE CERVIX THAT RESULTED IN A PIERCED SHEATH. A SUBSEQUENT FLUID LOSS ALARM OCCURRED AND HEATED SALINE, WITH A TEMPERATURE OF 89 DEGREES CELSIUS, WAS OBSERVED TO BE LEAKING FROM THE PUNCTURED SHEATH. THIS CAUSED A SECOND-DEGREE BURN ON THE PATIENT'S EXTERNAL ANATOMY. THE BURN WAS TREATED WITH SILVADENE CREAM. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS "IN PAIN". 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
    573736 GENESYS HTA PROCERVA® DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - SPENCER M006580211

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other