BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEENEN PANCREATIC STENT

    MDR report key: 10592425 · Received September 28, 2020

    Report

    Report Number
    3005580113-2020-00415
    Event Type
    Injury
    Date Received
    September 28, 2020
    Date of Event
    August 23, 2009
    Report Date
    September 28, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PROCODE: FGE CATHETER, BILIARY, DIAGNOSTIC. (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE JOURNAL ARTICLE: COTE ET AL 2009 (GEENEN PS) ¿ ¿DIFFICULT BILIARY CANNULATION: USE OF PHYSICIAN-CONTROLLED WIRE-GUIDED CANNULATION OVER A PANCREATIC DUCT STENT TO REDUCE THE RATE OF PRECUT¿. THE PRIMARY OUTCOME WAS THE RATE OF SUCCESSFUL BILIARY CANNULATION WITHOUT PERFORMING A PRECUT SPHINCTEROTOMY. IF BILIARY CANNULATION IS UNSUCCESSFUL, THE PD IS CANNULATED AND A 0.025- OR 0.035-INCH GUIDEWIRE IS ADVANCED TO THE LEVEL OF THE MID PANCREATIC BODY TO ALLOW PLACEMENT OF A SOFT POLYETHYLENE STENT. THE TYPE OF STENT IS LEFT TO THE DISCRETION OF THE ENDOSCOPIST, EITHER A 4F (IF USING A 0.025-INCH WIRE) OR 5F STENT WITH AN EXTERNAL PIGTAIL AND SINGLE INTERNAL FLANGE (FREEMAN PANCREATIC STENT; HOBBS MEDICAL INC, STAFFORD SPRINGS, CONN) OR A 5F STENT WITH A DOUBLE EXTERNAL AND SINGLE INTERNAL FLANGE (GEENEN PANCREATIC STENT; COOK MEDICAL, BLOOMINGTON, IND). THE INTERNAL FLANGE IS OCCASIONALLY REMOVED TO PROMOTE SPONTANEOUS PASSAGE OF THE STENT AFTER THE PROCEDURE. A PANCREATIC SPHINCTEROTOMY WAS NOT PERFORMED BEFORE DEPLOYING THE PD STENT. THE STENT MAY BE DEPLOYED BY USING THE SPHINCTEROTOME AS A PUSHER. ONCE THE STENT IS ADVANCED TO ITS DESIRED POSITION, THE WIRE IS PULLED BACK INTO THE SPHINCTEROTOME AND ATTEMPTS AT BILIARY CANNULATION RESUME. PHYSICIAN-CONTROLLED WGC OF THE BILE DUCT IS THEN ATTEMPTED OVER THE PD STENT. IF CANNULATION IS UNSUCCESSFUL AFTER SEVERAL MINUTES, A PRECUT SPHINCTEROTOMY IS PER-FORMED OVER THE PD STENT OR THE PROCEDURE IS TERMINATED AND THE PATIENT RESCHEDULED FOR ANOTHER ATTEMPT. 5F GEENEN (COOK MEDICAL) (N = 31). THERE WERE 4 (5.3%) CASES OF MILD POST-ERCP PANCREATITIS, 2 OF WHICH OCCURRED IN PATIENTS WHO HAD THEIR PD STENT REMOVED AT THE COMPLETION OF THE PROCEDURE. THIS FILE IS ALSO RELATED TO OFF LABEL USE AS THE DEVICE WAS USED TO FACILITATE BILIARY CANNULATION & POTENTIALLY ALTERING THE SHAPE OF THE STENT "THE INTERNAL FLANGE IS OCCASIONALLY REMOVED TO PROMOTE SPONTANEOUS PASSAGE OF THE STENT AFTER THE PROCEDURE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056800 GEENEN PANCREATIC STENT FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention