BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMON BILIARY STENT

    MDR report key: 20024525 · Received August 22, 2024

    Report

    Report Number
    3001845648-2024-00509
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 5, 2022
    Report Date
    January 2, 2025
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    DEVICE EVALUATION: THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE, "THE ROLE OF ANTIBIOTICS IN ENDOSCOPIC TRANSMURAL DRAINAGE OF POST-INFLAMMATORY PANCREATIC AND PERIPANCREATIC FLUID COLLECTIONS". THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. ABNORMAL USE COMPLAINTS ARE CONSIDERED TO BE BEYOND ANY FURTHER REASONABLE MEANS OF INTERFACE-RELATED RISK CONTROL BY THE MANUFACTURER. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. IT SHOULD BE NOTED THAT THIS FILE IS RELATED TO ANOTHER COMPLAINTS FILE. FOR DETAILS OF THE OTHER INVESTIGATION PLEASE REFER TO PRS: (B)(4). MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL ZIMMON BILIARY STENTS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. AS THE LOT NUMBER IS UNKNOWN A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED. INSTRUCTIONS FOR USE AND/LABEL: AS PER THE INSTRUCTIONS FOR USE, IFU0045 WHICH INFORMS THE USER ABOUT INTENDED USE ¿THIS DEVICE IS USED TO DRAIN OBSTRUCTED BILIARY DUCTS.¿ AS PER THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0045, WHICH INFORMS THE USER TO ¿THIS DEVICE IS INTENDED FOR SINGLE USE ONLY. ATTEMPTS TO REPROCESS, RESTERILIZE, AND/OR REUSE MAY LEAD TO DEVICE FAILURE AND/OR TRANSMISSION OF DISEASE. DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE.¿ THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. (IFU0045). IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE ABNORMAL USE OF THE DEVICE. FROM THE INFORMATION AVAILABLE, THE ZIMMON BILIARY STENT WAS USED FOR TRANSMURAL DRAINAGE OF POST INFLAMMATORY PANCREATIC AND PERIPANCREATIC FLUID COLLECTIONS, THIS WAS CONFIRMED BY OUR MEDICAL ADVISOR AS ABNORMAL USE. AS PREVIOUSLY MENTIONED, THE IFU (IFU0045) STATES "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 IN THE INTENDED USE.¿ THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU WITH RESPECT TO THE INTENDED USE OF THE DEVICE. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. THIS COMPLAINT PERTAINS TO THE OFF-LABEL USE OF THE ZIMMON BILIARY STENT FOR TRANSMURAL DRAINAGE OF POST-INFLAMMATORY PANCREATIC AND PERIPANCREATIC FLUID COLLECTIONS. PATIENT OUTCOME: NO HEALTH CONSEQUENCES OR IMPACT, AND NO CLINICAL SIGNS, SYMPTOMS, OR CONDITIONS WERE REPORTED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE ROOT CAUSE OF ABNORMAL USE WAS DETERMINED FROM THE AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    JAGIELSKI ET AL 2022 (C) ¿ THE ROLE OF ANTIBIOTICS IN ENDOSCOPIC TRANSMURAL DRAINAGE OF POST-INFLAMMATORY PANCREATIC AND PERIPANCREATIC FLUID COLLECTIONS PLACEMENT OF THE PANCREATICOGASTRIC OR PANCREATICODUODENAL ANASTOMOSIS IN THE FORM OF A TRANSMURAL CYSTOSTOMY WAS PERFORMED UNDER EUS GUIDANCE (JAGIELSKI ET AL., 2018; JAGIELSKI AND JACKOWSKI, 2021). THE ANASTOMOSIS BETWEEN THE GASTROINTESTINAL LUMEN AND THE COLLECTION CAVITY WAS CREATED USING A 10 FR CYSTOTOME (CYSTOTOME CST-10, COOK ENDOSCOPY INC., NORTH CAROLINA, USA) AND DILATED WITH A HIGH-PRESSURE BALLOON WITH A DIAMETER OF UP TO 15 MM (COOK ENDOSCOPY OR BOSTON SCIENTIFIC). THROUGH THE STOMY, A TRANSMURAL METAL JAGIELSKI ET AL. THE ANTIBIOTICS IN ENDOSCOPIC DRAINAGE OF PPPFCS FOR ACTIVE TRANSMURAL DRAINAGE, A 7 FR OR 8.5 FR NASAL DRAIN (COOK ENDOSCOPY) AND 7 FR OR 8 FR DOUBLE PIGTAIL STENTS (COOK ENDOSCOPY) WERE INSERTED INTO THE COLLECTION CAVITY THROUGH THE LAMS. IN THE CASE OF PASSIVE (WITHOUT FLUSHING THROUGH NASOCYSTIC DRAINAGE) TRANSMURAL DRAINAGE, ONLY 7 FR OR 8.5 FR DOUBLE PIGTAIL STENTS (COOK ENDOSCOPY) WERE USED THROUGH LAMS. DRAINAGE SYSTEM IF THE TRANSMURAL DRAINAGE SYSTEM DID NOT DRAIN THE ENTIRE NECROTIC AREA OR IF TRANSMURAL DRAINAGE WAS UNSUCCESSFUL FOR WOPN PATIENTS, DIRECT ENDOSCOPIC NECROSECTOMY WAS PERFORMED. THIS COMPLAINT CAPTURES THE OFF LABEL USE: USE OF ZIMMON BILIARY STENT FOR TRANSMURAL DRAINAGE OF POST INFLAMMATORY PANCREATIC AND PERIPANCREATIC FLUID COLLECTIONS. NO ADVERSE EFFECTS TO THE PATIENT NOTED IN THIS STUDY.

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 02-JAN-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2273450 ZIMMON BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male