BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESYS HTA PROCERVA®

    MDR report key: 2896568 · Received January 4, 2013

    Report

    Report Number
    3005099803-2012-06439
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    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 COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE CAN NOT BE DETERMINED. DEVICE AVAILABLE FOR EVALUATION: DEVICE DISPOSED OF. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISPOSED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    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, WITH 2 MINUTES REMAINING IN THE ABLATION PHASE, THE PHYSICIAN OBSERVED A SMALL AMOUNT FLUID LEAKING FROM THE CERVIX. HE DOUSED THE VAGINA WITH COOL SALINE AND PACKED WET GAUZE AROUND CERVIX TO COMPLETE THE PROCEDURE. UPON REMOVING THE SHEATH, THE PHYSICIAN NOTICED A SMALL, WHITE, BURN MARK ON THE CERVIX. THE PHYSICIAN CLASSIFIED THE BURN AS SUPERFICIAL. TREATMENT INCLUDED SILVADENE CREAM AS WELL AS VICODIN AND MOTRIN FOR PAIN RELIEF. NO ANTIBIOTICS WERE NECESSARY OR PRESCRIBED. ADDITIONAL FOLLOW UP WITH THE PHYSICIAN'S OFFICE REVEALED THE PATIENT'S BURN HAS HEALED WELL WITH NO FURTHER TREATMENT REQUIRED NOR FOLLOW UP NECESSARY. FULL RECOVERY IS EXPECTED AS THE PATIENT IS DOING "WELL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5389 GENESYS HTA PROCERVA® DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - MARLBOROUGH M006580211

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention