BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NASAL PANCREATIC DRAINAGE SET

    MDR report key: 10505003 · Received September 8, 2020

    Report

    Report Number
    3001845648-2020-00583
    Event Type
    Injury
    Date Received
    September 8, 2020
    Date of Event
    June 2, 2015
    Report Date
    January 23, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # : K171623. DEVICE EVALUATION: THE NPDS DEVICE OF UNKNOWN RPN AND 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 STENT IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION NPDS DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0107-2) STATES THE FOLLOWING: ¿THE NASAL PANCREATIC DRAINAGE SET IS USED FOR TEMPORARY DRAINAGE OF THE 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 COULD BE ATTRIBUTED TO THE USER NOT READING OR FOLLOWING THE IFU. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE NPDS DEVICE WAS PLACED THROUGH THE STOMA WHICH IS CONSIDERED OFF-LABEL USE. THE IFU STATES THE DEVICE IS USED FOR TEMPORARY DRAINAGE OF THE PANCREATIC DUCT THROUGH THE NASAL PASSAGE BY USE OF AN INDWELLING CATHETER. IT IS POSSIBLE THAT THE OFF-LABEL USE OF THE NPDS DEVICE CAUSED AND/OR CONTRIBUTED TO THE DISLOCATION OF THE TRANSMURAL STENT. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE DISLOCATED TRANSMURAL STENT WAS REMOVED ENDOSCOPICALLY USING A DORMIA BASKET. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. PMA/510(K) # : K171623.

    Description of Event or Problem · 1

    SMOCZYNSKI ET AL 2015 ¿ ¿ENDOSCOPIC NECROSECTOMY UNDER FLUOROSCOPIC GUIDANCE ¿ A SINGLE CENTER EXPERIENCE¿. PROCEDURE: GASTROPANCREATIC AND DUODENOPANCREATIC FISTULAS WERE MADE UNDER ENDOSCOPIC ULTRASONOGRAPHY (EUS) GUIDANCE WITH CYSTOSTOME (CYSTOTOME CST-10, WILSON-COOK, IRELAND)(OFF LABEL USE). A FLUID SAMPLE FROM THE COLLECTION WAS TAKEN FOR MICROBIAL CULTURE AND TO ASSESS AMYLASE ACTIVITY. THE MORPHOLOGY OF THE FLUID ASPIRED ¿ DARK BROWN COLOR WITH VISIBLE FRAGMENTS OF NECROTIC TISSUES (DEBRIS) ¿ WAS THE BASIS OF WOPN DIAGNOSIS. THE STOMA BETWEEN THE LUMEN OF THE GASTROINTESTINAL TRACT AND THE CAVITY OF NECROTIC. COLLECTION WAS WIDENED USING A HIGH-PRESSURE BALLOON 20 MM IN DIAMETER (BOSTON SCIENTIFIC, USA). THROUGH THE STOMA A 7 FR OR 8 FR NASOCYSTIC DRAIN (WILSON-COOK, IRELAND) (OFF LABEL USE ¿ PLACED THROUGH STOMA) AND A ¿DOUBLE-PIGTAIL¿ 7 FR OR 10 FR STENT (WILSON COOK, IRELAND OR MAR FLOW, SWITZERLAND) WERE INSERTED INTO THE CAVITY OF THE COLLECTION. (OFF LABEL USE CIRL DO NOT MANUFACTURE A DOUBLE PIGTAIL PANCREATIC STENT, ONLY INTENDED FOR BILIARY USE) DISLOCATION OF A TRANSMURAL STENT INTO THE CAVITY OF THE WOPN DURING INTRODUCTION OF A NASAL DRAIN WAS OBSERVED IN 1 PATIENT. THE STENT WAS REMOVED ENDOSCOPICALLY USING A DORMIA BASKET. THIS FILE WILL CAPTURE THE OFF-LABEL USE OF THE NPDS THROUGH THE STOMA AND THE POTENTIAL THAT THE INTRODUCTION OF THE NASAL DRAIN DEVICE (NPDS-) CAUSED OR CONTRIBUTED TO THE DISLOCATION OF THE TRANSMURAL STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965104 NASAL PANCREATIC DRAINAGE SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention