BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESYS HTA PROCERVA®

    MDR report key: 2891001 · Received December 31, 2012

    Report

    Report Number
    3005099803-2012-06221
    Event Type
    Injury
    Date Received
    December 31, 2012
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): RECEIVED, NOT YET EVALUATED.THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE HAVE NOT YET DETERMINED THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MANUFACTURER'S REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED PRODUCT FOUND THAT UPON THE INITIAL ATTEMPT TO ENGAGE THE CASSETTE A 'CASSETTE ERROR' WAS RECEIVED. THE COMMUNICATIONS BOARD WAS REPLACED AND UPON THE SECOND ATTEMPT TO ENGAGE THE CASSETTE ANOTHER 'CASSETTE ERROR' WAS RECEIVED. FURTHER ENGINEERING ANALYSIS WAS ABLE TO DETERMINE THAT THE MOST LIKELY CAUSE OF THE 'CASSETTE ERROR' RECEIVED DURING PRODUCT ANALYSIS WAS RESIDUE PRESENT ON THE LEVEL SENSE BOARD. THERE WERE NO DEFECTS NOTED TO THE RETURNED DEVICE THAT WOULD HAVE CONTRIBUTED TO THE CERVICAL LEAK. BASED ON INFORMATION AVAILABLE AT THIS TIME, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION FOR THE EVENT IS ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GENESYS HTA (HYDROTHERMABLATION) PROCERVA PROCEDURE SET WAS USED DURING AN HTA PROCEDURE ON (B)(6), 2012. ACCORDING TO THE COMPLAINANT, DURING THE SEAL INTEGRITY PHASE, A FLUID LOSS ALARM WAS NOTED NECESSITATING THE PHYSICIAN TO UTILIZE A SECOND TENACULUM. AFTER RESUMING THE PROCEDURE, THE PHYSICIAN OBSERVED FLUID LEAKING FROM THE CERVIX APPROXIMATELY 2 MINUTES INTO THE ABLATION PHASE. THE LEAKING FLUID VARIED INITIALLY FROM A SMALL DROPS RISING TO A "COPIOUS" AMOUNT AFTER THE PATIENT MOVED. THE PHYSICIAN IMMEDIATELY TERMINATED THE PROCEDURE. SUBSEQUENTLY, THE PATIENT RECEIVED BURNS ON THE LOWER 1/3 OF VULVA AND A SMALL STREAK ON THE LEFT GLUTEAL REGION FROM A STREAKING DROP OF HOT SALINE. THE PHYSICIAN CLASSIFIED THE BURNS ALL AS FIRST DEGREE. TREATMENT INCLUDED SILVADENE CREAM AS WELL AS VICODIN AND NAPROSYN FOR PAIN RELIEF. NO ANTIBIOTICS WERE NECESSARY OR PRESCRIBED. AN ADDITIONAL ATTEMPT HAS BEEN MADE TO OBTAIN FOLLOW UP EVENT DETAILS WITH NO RESPONSE FROM THE CLINICIAN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GENESYS HTA (HYDROTHERMABLATION) PROCERVA PROCEDURE SET WAS USED DURING AN HTA PROCEDURE ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE SEAL INTEGRITY PHASE, A FLUID LOSS ALARM WAS NOTED NECESSITATING THE PHYSICIAN TO UTILIZE A SECOND TENACULUM. AFTER RESUMING THE PROCEDURE, THE PHYSICIAN OBSERVED FLUID LEAKING FROM THE CERVIX APPROXIMATELY 2 MINUTES INTO THE ABLATION PHASE. THE LEAKING FLUID VARIED INITIALLY FROM A SMALL DROPS RISING TO A 'COPIOUS' AMOUNT AFTER THE PATIENT MOVED. THE PHYSICIAN IMMEDIATELY TERMINATED THE PROCEDURE. SUBSEQUENTLY, THE PATIENT RECEIVED BURNS ON THE LOWER 1/3 OF VULVA AND A SMALL STREAK ON THE LEFT GLUTEAL REGION FROM A STREAKING DROP OF HOT SALINE. THE PHYSICIAN CLASSIFIED THE BURNS ALL AS FIRST DEGREE. TREATMENT INCLUDED SILVADENE CREAM AS WELL AS VICODIN AND NAPROSYN FOR PAIN RELIEF. NO ANTIBIOTICS WERE NECESSARY OR PRESCRIBED. 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
    1 GENESYS HTA PROCERVA® DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - MARLBOROUGH M006580211 0000044305

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention