BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMON BILIARY STENT

    MDR report key: 20023365 · Received August 21, 2024

    Report

    Report Number
    3001845648-2024-00496
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    January 17, 2018
    Report Date
    July 29, 2025
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    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

    CANCELLATION REPORT BEING SUBMITTED AS THIS EVENT NO LONGER MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING.

    Description of Event or Problem · 0

    JAGIELSKI 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. THIS COMPLAINT WAS OPENED TO CAPTURE THE OFF LABEL USE OF THE ZSO STENT FOR WALLED-OFF PANCREATIC NECROSIS (WOPN). AS PER IFU0045-7 THAT ACCOMPANIES THIS DEVICE " THE DEVICE IS USED TO DRAIN OBSTRUCTED BILIARY DUCTS." PATIENT OUTCOME: NO ADVERSE EFFECTS TO THE PATIENT NOTED IN THIS STUDY.

    Description of Event or Problem · 0

    CANCELLATION REPORT BEING SUBMITTED AS THIS EVENT NO LONGER MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2358182 ZIMMON BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male