BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEENEN PANCREATIC STENT

    MDR report key: 10605561 · Received September 30, 2020

    Report

    Report Number
    3001845648-2020-00692
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Date of Event
    August 23, 2009
    Report Date
    November 17, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K900923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION THE GEENEN PANCREATIC STENT OF UNKNOWN LOT NUMBER AND RPN INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE. "DIFFICULT BILIARY CANNULATION: USE OF PHYSICIAN-CONTROLLED WIRE-GUIDED CANNULATION OVER A PANCREATIC DUCT STENT TO REDUCE THE RATE OF PRECUT SPHINCTEROTOMY" COMPLAINTS (B)(4) WERE OPENED AS A RESULT OF THIS PAPER. THIS COMPLAINT COVERS THE OFF LABEL USE OF GEENEN PANCREATIC STENT TO FACILITY BILIARY CANNULATION. (RPN UNKNOWN) (B)(4) (3001845648-2020-00693) COVERS CASES OF MILD POST - ERCP PANCREATITIS. (RPN UNKNOWN) DOCUMENT REVIEW: AS THE RPN AND LOT NUMBER OF THE COMPLAINT DEVICES ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL GEENEN PANCREATIC STENT DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. THE INSTRUCTIONS OF USE (IFU0055-4) WHICH WOULD ACCOMPANY THIS DEVICE INSTRUCTS THE USER TO ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE.¿ IT SHOULD BE NOTED THAT THE DEVICE WAS USED OFF-LABEL, OUTSIDE ITS INTENDED USE STATED IN THE INSTRUCTIONS FOR USE (IFU0055-4) "THIS DEVICE IS USED TO DRAIN OBSTRUCTED PANCREATIC DUCTS" AND IN THE NOTES SECTION ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE.¿ 4 PATIENTS WERE INVOLVED IN THIS STUDY AND ACCORDING TO THE INFORMATION RECEIVED GEENEN PANCREATIC 50 STENTS WERE USED. THIS IS REGARDED AS OFF LABEL USE AS THE DEVICE WAS USED FOR BILIARY CANNULATION. ACCORDING TO OUR CLINICAL ADVISER (B)(4) PASSED SPONTANEOUSLY BASED ON ABDOMINAL FILMS OBTAINED 14 DAYS AFTER THE PROCEDURE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS OUTSIDE ITS STATED INTENDED USE IT MAY LEAD TO OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. WHERE THE GEENEN PANCREATIC STENT WAS USED TO FACILITATE BILIARY CANNULATION. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION RECEIVED THE (B)(4) PASSED SPONTANEOUSLY BASED ON ABDOMINAL FILMS OBTAINED 14 DAYS AFTER THE PROCEDURE COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    COMPLAINT RECEIVED FROM INTERNAL PERSONNEL VIA E-MAIL ON 14SEP2020; DID (B)(6) 2020. AS REPORTED TO CUSTOMER RELATIONS: "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. AMONG 50 STENTS THAT WERE LEFT IN PLACE, 20 (40.0%) PASSED SPONTANEOUSLY BASED ON ABDOMINAL FILMS OBTAINED 14 DAYS AFTER THE PROCEDURE. OF THESE, 16 (80%) WERE HOBBS STENTS 5F GEENEN (COOK MEDICAL) (N = 31). THIS FILE WILL CAPTURE: OFF LABEL USE (25 DEVICES): 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" MIGRATION (4 PATIENTS): AMONG 50 STENTS THAT WERE LEFT IN PLACE, 20 (40.0%) PASSED SPONTANEOUSLY BASED ON ABDOMINAL FILMS OBTAINED 14 DAYS AFTER THE PROCEDURE. 16 WERE HOBBS STENTS, THEREFORE 4 STENTS ARE POTENTIALLY GEENEN PANCREATIC. (ALSO RELATED TO OFF LABEL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071147 GEENEN PANCREATIC STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female