BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESYS HTA PROCERVA®

    MDR report key: 3841062 · Received May 30, 2014

    Report

    Report Number
    3005099803-2014-02090
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT AGE OF THE PATIENT IS UNKNOWN,HOWEVER, IT WAS REPORTED THE PATIENT WAS OVER 18 YEARS. 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, THE PATIENT WAS UNDER GENERAL ANESTHESIA FOR THE PROCEDURE. NO ANATOMY ISSUES WERE NOTED. THE REPORTER ADDED THAT A TENACULUM WAS APPLIED AND THE TENACULUM STABILIZER WAS USED. FIVE MINUTES INTO THE ABLATION PHASE, THE PATIENT MOVED, WHICH CAUSED THE SHEATH TO BE INADVERTENTLY REMOVED FROM THE CERVIX. HOT SALINE LEAKED FROM THE SHEATH THAT RESULTED TO A SECOND DEGREE BURN INVOLVING THE VAGINAL CANAL. THE BURN WAS DESCRIBED AS "SKIN TURNING WHITE AND LOOSE." THE SITE ALSO CLAIMS THAT A FLUID LOSS ALARM OCCURED DURING THE PROCEDURE. THE PROCEDURE WAS ABORTED DUE TO THIS EVENT AND THE PATIENT WAS TREATED WITH SILVADENE CREAM. THE PATIENT WAS FINE AND SENT HOME FOLLOWING THE PROCEDURE. ABOUT TWO WEEKS LATER, PATIENT MADE A FOLLOW-UP VISIT WITH THE PHYSICIAN AND WAS NOTED TO BE FINE WITH NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318486 GENESYS HTA PROCERVA® DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - SPENCER M006580210 16294280

    Patients

    Seq Age Sex Outcome Treatment
    1 Other