BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESYS HTA PROCERVA®

    MDR report key: 3120395 · Received May 20, 2013

    Report

    Report Number
    3005099803-2013-03895
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THERE WAS A HOLE COMPLETELY THROUGH THE CSA OF RIGID TUBE ABOUT 3.5 CM FROM THE DISTAL END OF THE SHEATH. FOREIGN MATTER AND BLOOD RESIDUE WAS OBSERVED IN THE SHEATH ASSEMBLY. A 20.5% BLOCKAGE OF THE SIEVE TIP WAS ALSO NOTED. AS A HOLE WAS OBSERVED IN THE SHEATH DURING ANALYSIS OF THE RETURNED DEVICE, THE COMPLAINT WAS CONFIRMED. THE PUNCTURED SHEATH WAS MOST LIKELY CAUSED BY A TENACULUM USED DURING THE PROCEDURE. IN THIS CASE, THE CERVICAL LEAK AND RESULTING PATIENT BURN WERE MOST LIKELY THE RESULT OF THE PUNCTURED SHEATH. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION FOR THIS EVENT IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE PATIENT'S EXACT AGE IS UNKNOWN, THE PATIENT IS OVER 18 YEARS OF AGE.

    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 SALINE WAS SEEN LEAKING FROM THE PATIENT'S CERVIX. THE SITE HAD RECEIVED SOME FLUID LOSS ALARMS DURING ABLATION AND ABORTED THE PROCEDURE FOLLOWING THE CERVICAL LEAK. FOLLOWING THE PROCEDURE WHEN THE SHEATH WAS CHECKED, A PUNCTURE HOLE WAS NOTED APPROXIMATE AN INCH FROM THE TIP. THE PATIENT RECEIVED BURNS ON HER LABIA AND VAGINA. THE BURNS WERE TREATED WITH SILVADENE CREAM. ABLATION WAS CONSIDERED COMPLETED FOLLOWING THE PROCEDURE. FOLLOW UP WITH THE PHYSICIAN ON (B)()6 2013 CONFIRMED THAT THE PATIENT RECEIVED SECOND DEGREE BURNS TO HER LABIA AND VAGINA, BUT IS RECOVERING WELL WITH NO FURTHER COMPLICATIONS.

    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 SALINE WAS SEEN LEAKING FROM THE PATIENT'S CERVIX. THE SITE HAD RECEIVED SOME FLUID LOSS ALARMS DURING ABLATION AND ABORTED THE PROCEDURE FOLLOWING THE CERVICAL LEAK. FOLLOWING THE PROCEDURE WHEN THE SHEATH WAS CHECKED, A PUNCTURE HOLE WAS NOTED APPROXIMATE AN INCH FROM THE TIP. THE PATIENT RECEIVED BURNS ON HER LABIA AND VAGINA. THE BURNS WERE TREATED WITH SILVADINE CREAM. ABLATION WAS CONSIDERED COMPLETED FOLLOWING THE PROCEDURE. FOLLOW UP WITH THE PHYSICIAN ON (B)(6) 2013 CONFIRMED THAT THE PATIENT RECEIVED SECOND DEGREE BURNS TO HER LABIA AND VAGINA, BUT IS RECOVERING WELL WITH NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222114 GENESYS HTA PROCERVA® DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - MARLBOROUGH M006580211 0000045299

    Patients

    Seq Age Sex Outcome Treatment
    1 Other