BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HABIB ENDOHPB

    MDR report key: 16269103 · Received January 30, 2023

    Report

    Report Number
    3005099803-2023-00324
    Event Type
    Injury
    Date Received
    January 30, 2023
    Date of Event
    November 1, 2010
    Report Date
    January 30, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    UDI-DI
    08714729981909
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    APPROXIMATED BASED ON THE MONTH AND YEAR THE FIRST PROCEDURES WERE PERFORMED. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. LITERATURE SOURCE: DOLAK, W., SCHREIBER, F., SCHWAIGHOFER, H., GSCHWANTLER, M., PLIESCHNEGGER W., ZIACHEHABI, A., MAYER, A., KRAMER, L., KOPECKY, A., SCHRUTKA-KOLBL, C., WOLKERSDORFER, G., MADL, C., BERR, F., TRAUNER, M., PUSPOK, A. ENDOSCOPIC RADIOFREQUENCY ABLATION FOR MALIGNANT BILIARY OBSTRUCTION: A NATIONWIDE RETROSPECTIVE STUDY OF 84 CONSECUTIVE APPLICATIONS. SPRINGER SCIENCE+BUSINESS MEDIA NEW YORK 2013; 28: 854-860. (B)(4).

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING A HABIB RF CATHETER THROUGH THE ARTICLE "ENDOSCOPIC RADIOFREQUENCY ABLATION FOR MALIGNANT BILIARY OBSTRUCTION: A NATIONWIDE RETROSPECTIVE STUDY OF 84 CONSECUTIVE APPLICATIONS" BY DR. WERNER DOLAK, ET AL. A TOTAL OF 58 PATIENTS UNDERWENT 84 RADIOFREQUENCY ABLATION PROCEDURES TO TREAT A MALIGNANT BILIARY OBSTRUCTION PERFORMED IN BETWEEN NOVEMBER 2010 AND DECEMBER 2012. ALL 84 RFA PROCEDURES WERE CONDUCTED WITHOUT ANY TECHNICAL PROBLEMS; 78 WERE PERFORMED VIA ERCP AND 6 WERE PERFORMED VIA A PERCUTANEOUS APPROACH. A TOTAL OF 15 RFA PROCEDURES WERE PERFORMED WITHIN A PREVIOUSLY IMPLANTED SELF-EXPANDING METAL STENT. ACCORDING TO THE LITERATURE, ON ONE RFA PROCEDURE, A 10W WAS APPLIED FOR 90 SECONDS AT SIX DIFFERENT STRICTURE LOCATIONS IN THE COMMON BILE DUCT AND BOTH MAIN BILIARY BRANCHES. HOWEVER, A PARTIAL LIVER INFARCTION WAS NOTED AFTER THE RFA PROCEDURE. IT IS UNKNOWN HOW THE PARTIAL LIVER INFARCTION WAS ADDRESSED AND THE PATIENT WAS DISCHARGED AFTER 8 DAYS. FURTHERMORE, A COMPUTER TOMOGRAPHY SCAN (CT) WAS PERFORMED 3 MONTHS POST RFA PROCEDURE AND IT SHOWED NORMAL PERFUSION OF THE AFFECTED LIVER AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733684 HABIB ENDOHPB UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M00500070 08714729981909

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization