BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HABIB ENDOHPB

    MDR report key: 20041035 · Received August 22, 2024

    Report

    Report Number
    3005099803-2024-04036
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    August 31, 2023
    Report Date
    August 22, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    UDI-DI
    08714729981909
    PMA / PMN Number
    K231533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE LITERATURE WAS PUBLISHED. BLOCKS D4, H4: THE LOT NUMBER OF THE SUSPECT DEVICE WAS NOT PROVIDED IN THE LITERATURE; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK G2: LITERATURE SOURCE: JAROSOVA, J., ET AL. ENDOLUMINAL RADIOFREQUENCY ABLATION IN PATIENTS WITH MALIGNANT BILIARY OBSTRUCTION: A RANDOMISED TRIAL. GUT 2023; 72:2286-2293. DOI: 10.1136/GUTJNL-2023-329700. BLOCK H6: IMDRF PATIENT CODE E1021 CAPTURES THE REPORTABLE EVENT OF PANCREATITIS. IMDRF PATIENT CODE E172001 CAPTURES THE REPORTABLE EVENT OF LIVER ABSCESS. IMDRF PATIENT CODE E1109 CAPTURES THE REPORTABLE EVENT OF CHOLANGITIS. IMDRF PATIENT CODE E2326 CAPTURES THE REPORTABLE EVENT OF CHOLECYSTITIS. IMDRF IMPACT CODE F2303 CAPTURES THE ANTIBIOTICS TREATMENT PROVIDED. IMDRF IMPACT CODE F23 IS BEING USED TO CAPTURE THE REPEAT INTERVENTION TO ADDRESS THE CHOLANGITIS AND THE PERCUTANEOUS DRAINAGE TO ADDRESS THE LIVER ABSCESS.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING A HABIB EUS RFA CATHETER THROUGH THE ARTICLE, ENDOLUMINAL RADIOFREQUENCY ABLATION IN PATIENTS WITH MALIGNANT BILIARY OBSTRUCTION: A RANDOMISED TRIAL, BY JANA JAROSOVA, ET AL. PER THE ARTICLE, A HABIB EUS RFA CATHETER WAS USED TO TREAT CHOLANGIOCARCINOMA AND PANCREATIC DUCTAL ADENOCARCINOMA DURING AN ENDOLUMINAL RADIOFREQUENCY ABLATION (RFA) PLUS STENTING PERFORMED BETWEEN 2016 AND 2021. ONE PATIENT DEVELOPED MILD POST-PROCEDURAL PANCREATITIS. FOUR PATIENTS DEVELOPED ACUTE CHOLANGITIS AND WERE SUCCESSFULLY TREATED WITH ANTIBIOTICS. THE CHOLANGITIS OCCURRED EARLY AFTER THE PROCEDURE IN TWO OF THOSE FOUR PATIENTS, REQUIRING A REPEATED INTERVENTION. FURTHERMORE, ONE PATIENT WITH ACUTE CHOLANGITIS GOT COMPLICATED BY THE DEVELOPMENT OF A LIVER ABSCESS BUT WAS SUCCESSFULLY TREATED WITH PERCUTANEOUS DRAINAGE. LASTLY, ONE PATIENT DEVELOPED CHOLECYSTITIS, WHICH WAS RESOLVED WITH INTRAVENOUS ANTIBIOTICS. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1742649 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