BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESYS HTA PROCERVA?

    MDR report key: 3836539 · Received May 28, 2014

    Report

    Report Number
    3005099803-2014-02072
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    March 10, 2014
    Report Date
    April 30, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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, THE PROCEDURE WAS COMPLETED WITH NO INDICATION OF INJURY OR MALFUNCTION OF THE DEVICE ON THE DAY OF THE PROCEDURE. THE PATIENT HAD BEEN UNDER LOCAL ANESTHESIA AND THERE WAS NOTHING UNUSUAL WITH THE PATIENT'S ANATOMY. THE CERVIX WAS DILATED TO 8MM, AND TWO SINGLE TOOTHED TENACULUMS WERE CLAMPED ON BOTH SIDES OF THE CERVIX AND THE SHEATH WAS NOT MOVED EXCESSIVELY DURING THE PROCEDURE. THE SITE CLAIMS THAT A CERVICAL LEAK OCCURRED DURING THE PROCEDURE AND ALSO INDICATED THAT THERE WERE FLUID LOSS ALARMS DURING THE PROCEDURE. THE PATIENT WAS FINE AT THE CONCLUSION OF THE PROCEDURE. ACCORDING TO THE REPORTER AND PATIENT, NO INDICATION OF BURN OR INJURY WAS EVIDENT ON THE DAY OF THE HTA. ON THE EVENING OF THE PROCEDURE DATE, THE PATIENT CAME BACK TO THE CLINIC WITH COMPLAINTS OF NAUSEA AND VOMITING, AND WAS TREATED WITH ZOFRAN FOR THE SYMPTOMS AND IV FLUIDS FOR HYDRATION. NO HOSPITALIZATION WAS REQUIRED, AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION. THE FOLLOWING DAY, THE PATIENT REPORTED SLIGHT VAGINAL DISCHARGE. ON (B)(6), TEN DAYS FOLLOWING THE CASE, THE PATIENT REPORTED THAT HER VAGINAL DISCHARGE WAS HEAVIER THAN PREVIOUSLY REPORTED. ON PHYSICAL EXAMINATION, A BLISTER OF APPROXIMATELY 10X1.5CM IN SIZE WAS OBSERVED ON THE GLUTEAL AREA WITH SOME HYPERGRANULATED TISSUES. THE BURN WAS CLASSIFIED BY THE PHYSICIAN AS SECOND DEGREE, WHICH EXTENDED INTO THE SUBCUTANEOUS TISSUE JUST BELOW THE SKIN. THE BURN WAS CLEANSED WITH SALINE SOLUTION AND TREATED WITH SILVADENE CREAM. THE PATIENT UNDERWENT DEBRIDEMENT PROCEDURE AND WAS TREATED WITH AQUACEL AG. THE PATIENT WAS DISCHARGED IN STABLE CONDITION AFTER THE PROCEDURE ON (B)(6) 2014, FOLLOW-UP CHECK-UP REVEALED THAT THE WOUNDS HAVE HEALED COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313319 GENESYS HTA PROCERVA? DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - SPENCER UNK675

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention