BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESYS HTA PROCERVA®

    MDR report key: 3090183 · Received May 2, 2013

    Report

    Report Number
    3005099803-2013-03160
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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, DURING THE ABLATION PHASE OF THE PROCEDURE WHEN THE SALINE WAS AT 80 DEGREES CELSIUS, THE PATIENT COUGHED. THERE WAS A FLUID LOSS ALARM AND SALINE WAS NOTED TO BE LEAKING OUT OF THE PATIENT'S CERVIX. THE PROCEDURE WAS ABANDONED DUE TO THIS EVENT. A TENACULUM STABILIZER HAD BEEN USED DURING THE PROCEDURE AND THE PATIENT'S CERVIX WAS NOTED TO BE VERY SOFT, THEREFORE, THE PHYSICIAN UNDER DILATED. THE SITE STATED THAT NO BURN WAS CONFIRMED FOR THE PATIENT. NO PATIENT COMPLICATIONS AS A RESULT OF THIS ISSUE AND THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192055 GENESYS HTA PROCERVA® DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - MARLBOROUGH M006580210 0000044396

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR