BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESYS HTA PROCERVA®

    MDR report key: 3140458 · Received May 31, 2013

    Report

    Report Number
    3005099803-2013-04594
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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, THE PATIENT WAS PREOPERATIVELY PRESCRIBED CYTOTEC AND WAS REPORTED TO HAVE A STENOTIC CERVIX THAT WAS BARELY DILATED FOR THE PROCEDURE. DURING THE PROCEDURE THEY HAD A 10 CC FLUID LOSS AT 3 MINUTES INTO ABLATION AND AT EIGHT MINUTES INTO ABLATION, A FLUID LOSS A 10CC WAS AGAIN REPORTED WITH NO VISIBLE FLUID LOSS FOR EITHER AT THE CERVICAL OS. PHYSICIAN APPLIED A SECOND TENACULUM AT THE CERVIX AT THE 3 O'CLOCK POSITION. THE PHYSICIAN RECEIVED A 3RD 10CC FLUID LOSS ALARM AT THE SAME TIME PATIENT COMMENTED THAT SHE FELT A HOT SENSATION IN HER VAGINA. COLD SALINE WAS IMMEDIATELY APPLIED AND THE MACHINE WENT INTO COOL DOWN. COOL SALINE WAS THEN POURED INTO THE VAGINA. UPON HYSTEROSCOPY NO EVIDENCE OF BURN WAS NOTED AND NO TREATMENT WAS PROVIDED FOR THE ISSUE. THERE WERE NO REPORTED PATENT COMPLICATIONS AND THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241267 GENESYS HTA PROCERVA® DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - MARLBOROUGH M006580210 0000044396

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR