BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 15673392 · Received October 26, 2022

    Report

    Report Number
    3001845648-2022-00732
    Event Type
    Malfunction
    Date Received
    October 26, 2022
    Date of Event
    June 4, 2021
    Report Date
    January 10, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    POSSIBLE PMA/510(K) # FOR COOK MEDICAL NASAL DRAINAGE TUBE: K180868, K171623 INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    POSSIBLE PMA/510(K) # FOR COOK MEDICAL NASAL DRAINAGE TUBE: K180868. K171623. DEVICE EVALUATION: THE NPDS DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW: AS THE LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL NPDS DEVICES ARE SUBJECT TO VISUAL A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: ¿THE NASAL PANCREATIC DRAINAGE SET IS USED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE PANCREATIC DUCT THROUGH THE NASAL PASSAGE BY USE OF AN INDWELLING CATHETER¿. IT SHOULD BE NOTED THAT THE JAPANESE INSERT STATES THE FOLLOWING: "THIS DEVICE IS USED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE BILIARY OR PANCREATIC DUCT THROUGH THE NASAL PASSAGE BY USE OF AN INDWELLING CATHETER." THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF OFF-LABEL USE WAS IDENTIFIED FROM THE AVAILABLE INFORMATION. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT PLACEMENT OF THE NASAL DRAINAGE TUBE INTO A CYST WOULD BE CONSIDERED OFF LABEL USE AS PER THE IFU, THE DEVICE IS INTENDED TO BE USED FOR TEMPORARY ENDOSCOPIC DRAINAGE OF THE PANCREATIC DUCT. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, 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.

    Description of Event or Problem · 0

    WATANABE 2021 ¿ ¿UTILITY OF ENDOSCOPIC TRANSPAPILLARY PANCREATIC CYST DRAINAGE FOR INTRADUCTAL PAPILLARY MUCINOUS NEOPLASM INFECTION¿. THE PATIENT RECEIVED THE SAME ANTIBIOTICS AS ON PREVIOUS PRESENTATION, BUT THE INFLAMMATORY RESPONSE HAD PROGRESSED FURTHER. CYST DRAINAGE WAS REQUIRED TO CONTROL INFLAMMATION, AND ENDOSCOPIC TRANSPAPILLARY PANCREATIC CYST DRAINAGE WAS PERFORMED. NO EXPANSION OF THE PANCREATIC DUCT ORIFICE AND MUCUS DRAINAGE IN DUODENAL PAPILLA WAS OBSERVED. THE DIAMETER OF THE MPD WAS SLIGHTLY DILATED TO 3.4 MM; THE CYST CONNECTED WITH THE MPD WAS VISUALISED USING ENDOSCOPIC RETROGRADE PANCREATOGRAPHY. A CATHETER WAS INSERTED INTO THE CYST, AND A VISCOUS YELLOWISH-WHITE PUS WAS ASPIRATED FROM IT. A NASOCYSTIC DRAINAGE TUBE (COOK MEDICAL JAPAN, TOKYO, JAPAN) WAS PLACED INTO THE CYST AND CONTINUOUS DRAINAGE WAS PERFORMED. FOLLOW- UP CONTRAST- ENHANCED CT REVEALED IMPROVEMENT IN CYST HARDNESS AND CYST WALL THICKNESS, AND THE DIRTY FAT SIGN AROUND THE CYST DISAPPEARED. BOTH INFLAMMATORY RESPONSE AND ABDOMINAL SYMPTOMS IMPROVED 17 DAYS AFTER DRAINAGE, WHEREAS THE DRAINAGE TUBE WAS REMOVED 21 DAYS LATER. ALTHOUGH THE CYST DID NOT DISAPPEAR, SHE WAS DISCHARGED WITHOUT AN INTERNAL FISTULA FOR CYST DRAINAGE CONSIDERING THE IMPROVEMENT OF THE INFECTION. PLACEMENT OF A COOK NASAL DRAINAGE TUBE INTO A CYST WOULD BE CONSIDERED OFF-LABEL USE.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 10-JAN-23.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2801818 UNKNOWN FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female