BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HABIB ENDOHPB

    MDR report key: 20173007 · Received September 9, 2024

    Report

    Report Number
    3005099803-2024-03956
    Event Type
    Injury
    Date Received
    September 9, 2024
    Date of Event
    January 1, 2006
    Report Date
    September 9, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    UDI-DI
    08714729981909
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE: THIS REPORT WAS INITIALLY SUBMITTED ON AUGUST 16, 2024 PER FDA, ACKNOWLEDGEMENTS FOR THIS REPORT WERE SIGNIFICANTLY DELAYED DUE TO AN FDA SYSTEM INFRASTRUCTURE ISSUE AND THE FDA HAS DIRECTED BSC TO RESUBMIT THE EMDR IN ORDER TO GET IT ACCEPTED. BLOCK B3: EXACT EVENT DATE IS UNKNOWN; EVENT OCCURRED BETWEEN JANUARY 2006 AND DECEMBER 2021. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK G2: LITERATURE SOURCE: CHRISTIAN MOHRING., ET AL. COMPARISON BETWEEN REGULAR ADDITIONAL ENDOBILIARY RADIOFREQUENCY ABLATION AND PHOTODYNAMIC THERAPY IN PATIENTS WITH ADVANCED EXTRAHEPATIC CHOLANGIOCARCINOMA UNDER SYSTEMIC CHEMOTHERAPY. FRONTIERS IN ONCOLOGY. DOI: 10.3389/FONC.2023.1227036. BLOCK H6: IMDRF PATIENT CODE E050304 CAPTURES THE REPORTABLE EVENT OF THROMBOEMBOLIC EVENT. IMDRF PATIENT CODE E1008 CAPTURES THE REPORTABLE EVENT OF DIARRHEA. IMDRF PATIENT CODE E0514 CAPTURES THE REPORTABLE EVENT OF DEEP VEIN THROMBOSIS. IMDRF PATIENT CODE E0402 CAPTURES THE REPORTABLE EVENT OF ALLERGIC REACTION. IMDRF PATIENT CODE E2330 CAPTURES THE REPORTABLE EVENT OF PAINS. IMDRF PATIENT CODE E0301 CAPTURES THE REPORTABLE EVENT OF ANEMIA. IMDRF PATIENT CODE E1002 CAPTURES THE REPORTABLE EVENT OF ABDOMINAL PAIN. IMDRF PATIENT CODE E2320 CAPTURES THE REPORTABLE EVENT OF HYPERTENSION. IMDRF PATIENT CODE E2306 CAPTURES THE REPORTABLE EVENT OF ANOREXIA. IMDRF PATIENT CODE E1103 CAPTURES THE REPORTABLE EVENT OF HYPERBILIRUBINEMIA. IMDRF PATIENT CODE E1906 CAPTURES THE REPORTABLE EVENT OF INFECTION (OTHER THAN CHOLANGITIS), INFECTION WITHOUT NEUTROPENIA, AND INFECTION WITH NEUTROPENIA. IMDRF PATIENT CODE E0731 CAPTURES THE REPORTABLE EVENT OF PLEURAL EFFUSION. IMDRF PATIENT CODE E2401 CAPTURES THE REPORTABLE EVENT OF PHOTOTOXIC REACTION, ILEUS, AND OTHER HEMATOTOXIC SIDE EFFECTS. IMDRF PATIENT CODE E1709 CAPTURES THE REPORTABLE EVENT OF JAUNDICE. IMDRF PATIENT CODE E1104 CAPTURES THE REPORTABLE EVENT OF ALT ELEVATION, ASCITES, HEPATIC DYSFUNCTION, CREATININE ELEVATION. IMDRF PATIENT CODE E1032 CAPTURES THE REPORTABLE EVENT OF VOMITING. IMDRF PATIENT CODE E1714 CAPTURES THE REPORTABLE EVENT OF SKIN RASH. IMDRF PATIENT CODE E1208 CAPTURES THE REPORTABLE EVENT OF WEIGHT LOSS. IMDRF PATIENT CODE E130501 CAPTURES THE REPORTABLE EVENT OF CHRONIC KIDNEY FAILURE. IMDRF PATIENT CODE E2312 CAPTURES THE REPORTABLE EVENT OF FATIGUE. IMDRF PATIENT CODE E030202 CAPTURES THE REPORTABLE EVENT OF THROMBOPENIA . IMDRF PATIENT CODE E0306 CAPTURES THE REPORTABLE EVENT OF BILIARY SEPSIS. IMDRF PATIENT CODE E1109 CAPTURES THE REPORTABLE EVENT OF CHOLANGITIS. IMDRF PATIENT CODE E1020 CAPTURES THE REPORTABLE EVENT OF NAUSEA. IMDRF PATIENT CODE E1004 CAPTURES THE REPORTABLE EVENT OF ASCITES. IMDRF PATIENT CODE E0309 CAPTURES THE REPORTABLE EVENT OF LEUKOPENIA AND NEUTROPENIA.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING HABIB ENDOHPB BIPOLAR RADIOFREQUENCY CATHETER THROUGH THE ARTICLE TITLED, "COMPARISON BETWEEN REGULAR ADDITIONAL ENDOBILIARY RADIOFREQUENCY ABLATION AND PHOTODYNAMIC THERAPY IN PATIENTS WITH ADVANCED EXTRAHEPATIC CHOLANGIOCARCINOMA UNDER SYSTEMIC CHEMOTHERAPY" BY CHRISTIAN MOHRING, ET AL., PER THE ARTICLE, BETWEEN JANUARY 2006 TO DECEMBER 2021 THE FOLLOWING OCCURRED WITH STUDY PATIENTS: LEUKOPENIA, THROMBOPENIA, ANEMIA, NEUTROPENIA, OTHER HEMATOTOXIC SIDE EFFECTS, ALT ELEVATION, ASCITES, HEPATIC DYSFUNCTION, ANOREXIA, FATIGUE, NAUSEA, VOMIT, CREATININE ELEVATION, CHRONIC KIDNEY FAILURE, SKIN RASH, DIARRHEA, ALLERGIC REACTION, INFECTION WITHOUT NEUTROPENIA, INFECTION WITH NEUTROPENIA, DEEP VEIN THROMBOSIS, THROMBOEMBOLIC EVENT, HYPERBILIRUBINEMIA, JAUNDICE, ABDOMINAL PAIN, CHOLANGITIS, BILIARY SEPSIS, INFECTION (OTHER THAN CHOLANGITIS), WEIGHT LOSS, PAINS, PLEURAL EFFUSION, HYPERTENSION, ILEUS, PHOTOTOXIC REACTION AND FEVER. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS AND FULL LISTING OF PHYSICIANS AND HEALTHCARE FACILITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537675 HABIB ENDOHPB UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M00500070 08714729981909

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other