BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUIBREGTSE GUIDING CATHETER

    MDR report key: 13891658 · Received March 24, 2022

    Report

    Report Number
    3001845648-2022-00178
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    October 21, 2019
    Report Date
    September 6, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE HGC-1 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW: AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL HGC-6 DEVICES ARE SUBJECT TO VISUAL A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. THIS COMPLAINT WAS RAISED IN THE LITERATURE ARTICLE ZHOU ET AL 2019 ¿ ¿BILIARY SELF-EXPANDABLE METALLIC STENT COMBINED WITH IODINE-125 SEEDS STRAND IN THE TREATMENT OF HILAR MALIGNANT BILIARY OBSTRUCTION¿. THE STUDY AIMED TO PERFORM RETROSPECTIVE ANALYSIS OF THE EFFECTIVENESS AND SAFETY OF SEMS COMBINED WITH IODINE SEEDS STRAND IN THE TREATMENT OF PATIENTS WITH BISMUTH TYPE I-IV HILAR MALIGNANT BILIARY OBSTRUCTION (MBO). COMPLAINT FILES (B)(4) (3001845648-2022-00177 ), (B)(4), (B)(4) AND (B)(4) (3001845648-2022-00178) WERE RAISED AS A RESULT OF THIS ARTICLE. (B)(4) ZHOU ¿ ¿IODINE SEED GROUP: OFF LABEL USE¿. (B)(4) ZHOU ¿ ¿CONTROL GROUP: ASYMPTOMATIC AMYLASE INCREASE¿. (B)(4) ZHOU ¿ ¿CONTROL GROUP: SELF-LIMITED BILIARY HAEMORRHAGE¿. (B)(4) ZHOU ¿ ¿IODINE SEED GROUP: OFF LABEL USE HGC-6¿. PER ITF018-BILIARY STENT INTRODUCERS SECTION 3.2.4 ¿THE GUIDING CATHETER AND HUIBREGTSE GUIDING CATHETER ARE USED FOR ENDOSCOPIC STENT PLACEMENT TO DRAIN OBSTRUCTED BILIARY DUCTS.¿ ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF OFF LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. HGC DEVICES ARE INTENDED FOR ENDOSCOPIC BILIARY STENT PLACEMENT. PER THE LITERATURE ARTICLE THIS DEVICE WAS USED FOR IODINE SEED STRAND TREATMENT. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, NO ADVERSE EFFECTS REPORTED LINKED DIRECTLY TO GUIDING CATHETER. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    ZHOU ET AL 2019 ¿ ¿BILIARY SELF-EXPANDABLE METALLIC STENT COMBINED WITH IODINE-125 SEEDS STRAND IN THE TREATMENT OF HILAR MALIGNANT BILIARY OBSTRUCTION¿. SEED GROUP (OFF LABEL USE): THE 125I SEEDS STRAND, USED FOR LOADING THE SEEDS, WAS MADE BY INSERTING THE APPROPRIATE NUMBER OF 125I SEEDS INTO A 4F CATHETER (COOK MEDICAL, BLOOMINGTON, IN, USA) THAT WAS THEN HEAT SEALED AT EITHER END. SEMS AND 125I SEEDS STRAND IMPLANTATION: TWO HYDROPHILIC WIRES WERE ARRANGED ACROSS THE BILE DUCT STRICTURE. THE SEMS (COOK IRELAND), USUALLY 8 OR 10 MM IN DIAMETER AND 40¿100 MM IN LENGTH (ZIB6), WAS DEPLOYED VIA ONE WIRE. A 6F GUIDING CATHETER (COOK MEDICAL), USED FOR 125I SEED DEPLOYMENT, WAS INSERTED VIA THE OTHER WIRE. AFTER THE STENT WAS RELEASED, A PREPARED 125I SEEDS STRAND WAS INSERTED INTO THE 6F GUIDING CATHETER AND LOCATED AT THE BILE DUCT STENO-SIS. WHILE WITHDRAWING THE 6F GUIDING CATHETER, THE I SEEDS STRAND WAS RELEASED BETWEEN THE SEMS AND BILE DUCT WALL. FINALLY, A 7.0¿8.5F DRAINAGE CATHETER (COOK INC) WAS PLACED INDWELLING ABOVE THE SEMS. CONTROL GROUP: 36 PATIENTS (40 DEVICES) RECEIVED SEMS ONLY (ZIB6). OFF LABEL USE: 6F GUIDING CATHETER (HCG-1), USED FOR IODINE SEED DEPLOYMENT. NO ADVERSE EFFECTS REPORTED LINKED DIRECTLY TO GUIDING CATHETER.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330267 HUIBREGTSE GUIDING CATHETER FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male