BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMON PANCREATIC STENT

    MDR report key: 10614435 · Received October 1, 2020

    Report

    Report Number
    3001845648-2020-00722
    Event Type
    Malfunction
    Date Received
    October 1, 2020
    Date of Event
    February 17, 2014
    Report Date
    November 17, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K900923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION THE ZIMMON BILIARY 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 JOURNAL ARTICLE. "SEQUENTIAL ALGORITHM ANALYSIS TO FACILITATE SELECTIVE BILIARY ACCESS FOR DIFFICULT BILIARY CANNULATION IN ERCP: A PROSPECTIVE CLINICAL STUDY" THE COMPLAINT FILE (B)(4) IS THE ONLY FILE OPENED AS A RESULT OF THIS PAPER. THIS FILE COVERS THIS FILE COVERS THE OFF LABEL FOR PROPHYLACTIC USE OF THE ZIMMON BILIARY STENT, 5FR, THAT WAS USED. (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 ZIMMON BILIARY 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 FOR USE WHICH WOULD ACCOMPANY THIS DEVICE (IFU0045-7) 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 (IFU0045-7) "THIS DEVICE IS USED TO DRAIN OBSTRUCTED BILIARY DUCTS" AND IN THE NOTES SECTION ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE.¿ 711 PATIENTS WERE INVOLVED IN THIS STUDY AND ACCORDING TO THE INFORMATION RECEIVED PANCREATIC STENT WERE INSERTED IN ALL 711. IT WAS NOTED PANCREATIC STENTS WERE USED FOR BILIARY CANNULATION AND PLACED PROPHYLACTICALLY, THIS IS REGARDED AS OFF LABEL USE AS A PANCREATIC STENT WAS USED TO FACILITATE BILIARY CANNULATION AND AS THE STENT WAS PLACED PROPHYLACTICALLY. THE 36 STENTS WERE USED AND THEY WERE ALL ZIMMON 5FR PIGTAIL TYPE. ACCORDING TO OUR CLINICAL ADVISER THERE WAS NO COOK MEDICAL DEVICE CONTRIBUTION TO ADVERSE EVENTS. 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 PROPHYLACTIC USE OF THE DEVICE "AS THE STENTS WERE PLACED PROPHYLACTICALLY, ANY STENTS THAT DID NOT MIGRATE WERE REMOVED" IS NOT A STATED USE AS PER THE IFU AND THEREFORE HAS NOT BEING TESTED IN A CLINICAL SETTING. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION RECEIVED THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. CLOSURE DATE REVISED DUE TO LATE TRANSFER TO CI

    Description of Event or Problem · 0

    FINAL MDR BEING SUBMITTED DUE TO COMPLETION OF INVESTIGATION ON 17-NOV-2021

    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

    LEE ET AL. 2014 ¿SEQUENTIAL ALGORITHM ANALYSIS TO FACILITATE SELECTIVE BILIARY ACCESS FOR DIFFICULT BILIARY CANNULATION IN ERCP: A PROSPECTIVE CLINICAL STUDY¿ THIS PROSPECTIVE STUDY WAS DESIGNED TO EVALUATE A SEQUENTIAL CANNULATION PROTOCOL TO FACILITATE SELECTIVE BILIARY ACCESS FOR DBC. THE ALGORITHM WAS BASED ON THE SEQUENTIAL PERFORMANCE OF AN EARLY PRECUT FISTULOTOMY (EPF), DOUBLE-GUIDEWIRE CANNULATION (DGC) TECHNIQUE, AND PRECUT AFTER PLACEMENT OF A PANCREATIC STENT (PPS) IN FAILED WIRE-GUIDED CANNULATION DUE TO DBC DURING ERCP. A TOTAL OF 711 CONSECUTIVE PATIENTS WITH NAÏVE PAPILLAE WERE ENROLLED FROM SEPTEMBER 2010 TO AUGUST 2012. PATIENTS WHO SATISFIED THE FOLLOWING INCLUSION CRITERIA WERE ENROLLED: THOSE WITH NAÏVE PAPILLA WHO UNDERWENT ERCP FOR BILIARY ENDOTHERAPY, AGE = 18 YEARS, AND AGREEMENT TO PARTICIPATE IN THE STUDY. THE INITIAL CANNULATION WAS ATTEMPTED USING THE WIRE-GUIDED CANNULATION METHOD. THEN, EPF WAS PERFORMED FIRST IF PRIMARY WIRE-GUIDED CANNULATION FAILED BASED ON THE FOLLOWING CRITERIA: PAPILLA CONTACT > 5, CANNULATION TIME > 5 MIN, OR A HOOK-NOSESHAPED PAPILLA. NEXT, DGC WAS ATTEMPTED IF UNINTENTIONAL PANCREATIC DUCT CANNULATION OCCURRED MORE THAN 3 TIMES. THIRD, PPS WAS ATTEMPTED IF THE SUM OF PAPILLA CONTACT AND UNINTENTIONAL PANCREATIC DUCT CANNULATION EXCEEDED FIVE TIMES DURING THE TRIAL OF DGC. IF THE SUM OF PAPILLARY CONTACT AND UNINTENTIONAL PANCREATIC DUCT CANNULATION EXCEEDED 5 TIMES DESPITE ONGOING DGC, PPS WAS PERFORMED. AFTER PLACEMENT OF THE PANCREATIC STENT (SINGLE 6 OR 8 CM-LONG 5 F PIGTAIL-TYPE, ZIMMON; COOK ENDOSCOPY), A CUT WAS MADE FROM THE ORIFICE OF THE AMPULLA OF VATER ADJACENT TO THE PANCREATIC STENT. IF THE PANCREATIC STENT HAD NOT MIGRATED SPONTANEOUSLY WITHIN 1 WEEK, IT WAS REMOVED ENDOSCOPICALLY. THIS FILE WAS CREATED TO CAPTURE THE OFF LABEL USE OF THE ZIMMON 5FR, 6CM & 5FR 8CM PANCREATIC STENT- AS THIS PANCREATIC STENT WAS USED TO FACILITATE BILIARY CANNULATION AND AS THE STENT WAS PLACED PROPHYLACTICALLY. AS THE STENTS WERE PLACED PROPHYLACTICALLY, ANY STENTS THAT DID NOT MIGRATE WERE REMOVED. THIS FILE IS ALSO COVERING THE POTENTIAL MIGRATION OF THE STENT, THE PAPER DOES NOT OUTLINE HOW MANY STENT¿S DID MIGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080822 ZIMMON PANCREATIC STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male