BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROTHERMABLATOR PROCEDURE SET

    MDR report key: 1221206 · Received November 5, 2008

    Report

    Report Number
    3005099803-2008-06028
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION SINCE IT WAS DISPOSED OF; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A 5-PACK HYDROTHERMABLATOR (HTA) PROCEDURE SET WITH TENACULUM STABILIZER AND DISPOSABLE HEATER CANISTER WAS USED DURING A THERAPEUTIC HYDROTHERMAL ABLATION PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, DURING THE BEGINING OF PROCEDURE, IT WAS NOTED THAT THE PT HAD A VERY TIGHT CERVIX AND THE PHYSICIAN HAD TO START THE CASE WITH PEDIATRIC DILATORS. THE PHYSICIAN WENT IN FOR THE DIAGNOSTIC PHASE AND NOTICED THAT THE UTERUS WAS PERFORATED BY THE DILATOR. THIS OCCURRED DURING PREPARATION FOR THE PROCEDURE PRIOR TO THE HTA KIT BEING USED. THE PT WAS ADMITTED FOR OBSERVATION. THE PT'S CONDITION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROTHERMABLATOR PROCEDURE SET MNB BOSTON SCIENTIFIC CORPORATION M006560201 0000034681

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization