BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEENEN PANCREATIC STENT

    MDR report key: 20014003 · Received August 21, 2024

    Report

    Report Number
    3001845648-2024-00498
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    January 17, 2018
    Report Date
    October 4, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K900923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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

    THIS FILE WAS RAISED FROM LITERATURE TO CAPTURE USER ERROR - EXCEEDING INDWELLING TIME OF PANCREATIC STENTS. THIS FILE IS RELATED TO: 437795 "JAGIELSKI ET AL 2018 (C)- OFF LABEL USE." 437796 "JAGIELSKI ET AL 2018 (C)- OFF LABEL USE & BLEEDING." 437798 "JAGIELSKI ET AL 2018 (C) - OFF LABEL USE." 437799"JAGIELSKI ET AL 2018 (C)- OFF LABEL USE & BLEEDING." 438611 "JAGIELSKI ET AL 2018 (C) - OFF LABEL USE." USER/USE RELATED COMPLAINTS IS CONSIDERED FORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL PERFORM OUTSIDE OF INSTRUCTIONS FOR USE AND/OR LABELLING REQUIREMENTS. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU AND/LABEL. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. DEVICE EVALUATION: THE UNKNOWN DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. MANUFACTURING RECORDS: AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. 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 REVIEW HISTORICAL DATA: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE/LABEL: IT MAY BE NOTED THAT AS PER THE IFU THAT ACCOMPANIES THESE DEVICES, IFU0055, "THIS DEVICE SHOULD NOT BE LEFT INDWELLING FOR MORE THAN THREE MONTHS OR AS DIRECTED BY A PHYSICIAN. PERIODIC EVALUATION IS RECOMMENDED." THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. MEDICAL ADVISORS INPUT PROVIDED "USER ERROR - INDWELL PERIOD EXCEEDS 3 MONTHS". IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE USER ERROR OF THE DEVICE EXCEEDING THE RECOMMENDED INDWELL PERIOD OF 3 MONTHS AS PER THE INSTRUCTION FOR USE. AS PER THE IFU THAT ACCOMPANIES THESE DEVICES "THIS DEVICE SHOULD NOT BE LEFT INDWELLING FOR MORE THAN THREE MONTHS OR AS DIRECTED BY A PHYSICIAN. PERIODIC EVALUATION IS RECOMMENDED." USER/USE RELATED COMPLAINTS ARE CONSIDERED FORESEEN MISUSE THEREFORE, IT IS UNKNOWN HOW THE DEVICE WILL PERFORM OUTSIDE OF INSTRUCTIONS FOR USE AND/OR LABELLING REQUIREMENTS. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. SUMMARY: FILE WAS CREATED FROM LITERATURE TO CAPTURE USER ERROR - EXCEEDING INDWELLING TIME OF PANCREATIC STENTS. CONFIRMED QUANTITY OF 18 DEVICES, CONFIRMED USED. PATIENT OUTCOME, AS PER INFORMATION PROVIDED NO ADVERSE EFFECTS TO THE PATIENT NOTED IN THIS STUDY. INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE USER ERROR OF THE DEVICE EXCEEDING THE RECOMMENDED INDWELL PERIOD OF 3 MONTHS AS PER THE INSTRUCTION FOR USE. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    (B)(6) ET AL 2018 (C) ¿ ENDOSCOPIC TREATMENT OF WALLED-OFF PANCREATIC NECROSIS COMPLICATED WITH PANCREATICOCOLONIC FISTULA. SINCE 2011, THE PLACE OF FISTULOTOMY WAS CHOSEN UNDER EUS GUIDANCE. BETWEEN 2001 AND 2011 (CONVENTIONAL DRAINAGE), FISTULOTOMY WAS PERFORMED ON THE TOP OF THE LARGEST PROTUBERANCE OF THE NECROTIC COLLECTION INTO THE GASTROINTESTINAL WALL (65 PATIENTS). WHEN NO PROTUBERANCE WAS VISIBLE, THE DETERMINATION OF THE NECROGASTROSTOMY OR NECRODUODENOSTOMY SITE WAS MADE WITH THE HELP OF FLUOROSCOPY AFTER ADMINISTRATION OF CONTRAST MEDIUM EITHER VIA THE DUODENAL PAPILLA (IN THE PRESENCE OF A MAIN PANCREATIDUCT LEAK) IN 32 PATIENTS OR THROUGH A PERCUTANEOUS DRAIN IN 15 PATIENTS. ENTEROSTOMY WAS PERFORMED WITH A 7 FRENCH FISTULOTOME (HUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE HPC3, WILSON-COOK) OR A GIOVANNINI CYSTOSTOME (CYSTOTOME CST-10, WILSON-COOK). THE OPENING BETWEEN THE LUMEN OF THE GASTROINTESTINAL TRACT AND THE LUMEN OF THE NECROTIC COLLECTION WAS WIDENED WITH THE USE OF A ¿BOUGIE¿ TYPE DILATOR (SOEHENDRA BILIARY DILATION CATHETERS SBDC-8.5, SBDC10, WILSON-COOK) OR A HIGH-PRESSURE BALLOON (8 OR 20 MM, BOSTON SCIENTIFIC). A 7 FRENCH OR 8 FRENCH NASOCYSTIC DRAIN (BALTON OR WILSON-COOK) AND SEVERAL ¿DOUBLE-PIGTAIL¿ (7 FRENCH/8.5 FRENCH STENTS, WILSON COOK/MAR FLOW) OR 10 FRENCH STENTS BY WILSON COOK WERE INSERTED INTO THE CAVITY LUMEN OF THE COLLECTION. ERP WAS PERFORMED IN 18 OF 21 PATIENTS (85.71%). ENDOSCOPIC RETROGRADE PANCREATOGRAPHY (ERP) IN CASES OF A MAIN PANCREATIC DUCT (MPD) LEAK, SPHINCTEROTOMY WAS PERFORMED (OLYMPUS FLOWCUT KD-301Q0725 SPHINCTEROTOME) AND A PANCREATIC STENT WAS INSERTED INTO THE MAIN PANCREATIC DUCT (5¿10 FRENCH, GEENEN, ZIMMON PANCREATIC STENT, WILSON-COOK OR MAR FLOW). THE TRANSPAPILLARY PANCREATIC STENTS WERE EXCHANGED AFTER 3, 6, AND 12 MONTHS UNTIL NO LEAKAGE OF CONTRAST OUTSIDE THE DUCT COULD BE DEMONSTRATED. THIS COMPLAINT WAS OPENED TO CAPTURE USER ERROR - EXCEEDING INDWELLING TIME OF PANCREATIC STENTS. AS PER THE IFU THAT ACCOMPANIES THESE DEVICES, IFU0055-4, "THIS DEVICE SHOULD NOT BE LEFT INDWELLING FOR MORE THAT THREE MONTHS OR AS DIRECTED BY A PHYSICIAN. PERIODIC EVALUATION IS RECOMMENDED." NO ADVERSE EFFECTS TO THE PATIENT NOTED IN THIS STUDY.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 04-OCT-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2362452 GEENEN PANCREATIC STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male