BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVARRE BILIARY DRAIN

    MDR report key: 17180064 · Received June 22, 2023

    Report

    Report Number
    3006260740-2023-02546
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Date of Event
    August 31, 2018
    Report Date
    May 30, 2023
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    FGE
    PMA / PMN Number
    K955110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    JIA RUI KWAN, KEITH SHENG HNG LOW, RAHUL LOHAN AND VISHAL G SHELAT (2018). PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE CATHETER FRACTURE: A CASE REPORT. ANN HEPATOBILIARY PANCREATIC SURGERY, 22(3):282-286. DOI: 10.14701/AHBPS.2018.22.3.282. H10: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE IN JOURNAL OF ¿ANNALS OF HEPATO-BILIARY-PANCREATIC SURGERY¿ TITLED ¿PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE CATHETER FRACTURE: A CASE REPORT" THAT SOMETIME POST DRAINAGE CATHETER PLACEMENT, THE PATIENT ALLEGEDLY COMPLAINTS OF PAIN OVER THE DRAIN SITE AND INABILITY TO FLUSH THE RIGHT CATHETER. IT WAS FURTHER REPORTED THAT COMPUTED TOMOGRAPHY SCAN RESULT CONFIRMED A BREAK IN THE RIGHT PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE CATHETER NEAR THE LIVER CAPSULE, WITH A FOUR-CENTIMETER GAP BETWEEN THE ENDS, AS WELL AS A BREAK AT THE DISTAL SEGMENT. IT WAS ALSO REPORTED THAT THE CATHETER WAS FRACTURED AT TWO PLACES WITH THREE FRAGMENTS NEEDING REMOVAL. FURTHERMORE, THERE IS NO INFORMATION PROVIDED REGARDING ADDITIONAL INTERVENTION OR MEDICATION PRESCRIBED TO TREAT COMPLAINTS OF PAIN. HOWEVER, PERCUTANEOUS ATTEMPT AT REMOVAL OF THE PROXIMAL FRAGMENT WAS SUCCESSFULLY PERFORMED BUT MIDDLE AND THE DISTAL FRAGMENTS WERE UNSUCCESSFUL BECAUSE THE STRINGS OF THE CATHETER COULD NOT BE PULLED. REPORTEDLY, ALL THE CATHETER FRAGMENTS WERE SUCCESSFULLY REMOVED BY THE FORCEPS. THE PROCEDURE WAS COMPLETED BY EXCHANGING ANOTHER CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306830 NAVARRE BILIARY DRAIN CHRONIC CATHETERS FGE C.R. BARD, INC. (BASD) -3006260740 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female