BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 15657973 · Received October 24, 2022

    Report

    Report Number
    3001845648-2022-00714
    Event Type
    Malfunction
    Date Received
    October 24, 2022
    Date of Event
    January 10, 2022
    Report Date
    January 13, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    POSSIBLE 510K#'S: NPDS 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 (IFU0107) 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¿. 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 THE PLACEMENT OF A NASAL DRAIN THROUGH THE LAMS DEVICE IS CONSIDERED OFF LABEL. 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.

    Additional Manufacturer Narrative · 0

    POSSIBLE 510K#'S: ENBD, K180868. NPDS, K171623. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON THE 13-JAN-2023.

    Description of Event or Problem · 0

    JAGIELSKI 2022 ¿ ¿EARLY ENDOSCOPIC TREATMENT OF SYMPTOMATIC PANCREATIC NECROTIC COLLECTIONS¿. SINGLE TRANSLUMINAL GATEWAY TECHNIQUES (SGT): FISTULOTOMY WAS LOCATED WITH USE OF EUS. ENTEROSTOMY WAS PERFORMED USING CYSTOTOME (CYSTOTOME CST-10, COOK ENDOSCOPY). FISTULA BETWEEN THE GASTROINTESTINAL TRACT LUMEN AND NECROTIC COLLECTION WAS WIDENED USING A 15-MM HIGH-PRESSURE BALLOON (COOK ENDOSCOPY OR BOSTON SCIENTIFIC). THROUGH THE FISTULA, A LUMEN-APPOSING METAL STENT (LAMS) (DIAMETER, 16 MM; LENGTH, 30 OR 40 MM TAEWOONG MEDICAL OR OLYMPUS) WAS INSERTED TRANSMURALLY IN EACH CASE. SUBSEQUENTLY, THROUGH THE LAMS, 7- OR 8-FR NASAL DRAIN (COOK ENDOSCOPY) AND/OR A 7- OR 8.5-FR DOUBLE PIGTAIL ENDOSCOPIC STENT (COOK ENDOSCOPY) WERE INSERTED. MULTIPLE TRANSLUMINAL GATEWAY TECHNIQUES (MTGT): IN PATIENTS QUALIFIED FOR CREATION OF ANOTHER TRANSMURAL TRACT BETWEEN THE NECROTIC CAVITY AND THE GASTROINTESTINAL TRACT, THE SITE OF FISTULOTOMY WAS ALSO DETERMINED UNDER EUS GUIDANCE. ENTEROSTOMY WAS PERFORMED USING CYSTOTOME (CYSTOTOME CST-10, COOK ENDOSCOPY). THE FISTULA WAS DILATED USING A HIGH-PRESSURE 15-MM BALLOON (COOK ENDOSCOPY OR BOSTON SCIENTIFIC). SUBSEQUENTLY, A LAMS (DIAMETER, 16 MM; LENGTH, 30 OR 40 MM TAEWOONG MEDICAL OR OLYMPUS) WAS INSERTED TRANSMURALLY. THROUGH THE LAMS, A 7- OR 8-FR NASOCYSTIC DRAIN (COOK ENDOSCOPY) AND/OR A 7- OR 8.5-FR DOUBLE PIGTAIL ENDOSCOPIC STENT (COOK ENDOSCOPY) WERE INSERTED INTO THE NECROTIC COLLECTION. SINGLE TRANSLUMINAL GATEWAY TRANSCYSTIC MULTIPLE DRAINAGE (SGTMD): IN PATIENTS QUALIFIED FOR SGTMD SUB-SEQUENT ENDOSCOPIC PROCEDURES WERE PERFORMED AND A GUIDEWIRE WAS INTRODUCED IN THE NECROTIC SUBCAVITIES WITH FLUOROSCOPY GUIDANCE THROUGH THE TRANSMURAL TRACT CREATED BETWEEN THE NECROTIC COLLECTION AND THE GASTROINTES-TINAL LUMEN. THE CANALS BETWEEN THE NECROTIC SUBCAVITIES WERE DILATED WITH A 8-MM HIGH-PRESSURE BALLOON (BOS-TON SCIENTIFIC) UNDER FLUOROSCOPY AND ENDOSCOPY GUIDANCE. SUBSEQUENTLY, ANOTHER 7- OR 8-FR NASAL DRAIN (COOK ENDOSCOPY) AND/OR 7- OR 8.5-FR DOUBLE PIGTAIL STENT (COOK ENDOSCOPY) WERE INTRODUCED THROUGH THOSE CANALS AND THEIR DISTAL ENDS WERE DEPLOYED WITHIN NECROTIC SUBCAVITIES. DIRECT ENDOSCOPIC NECROSECTOMY (DEN)15. THE NASAL DRAIN WAS REMOVED AND THE GASTROSCOPE WAS INSERTED INTO THE NECROTIC COLLECTION THROUGH THE TRANSMURAL STENT. THE COLLECTION WAS FLUSHED SEVERAL TIMES WITH SALINE AND THE NECROTIC CONTENT WAS REMOVED. USING A 15¿20-MM EXTRACTION BALLOON (COOK ENDOSCOPY) AND DORMIA BASKET (COOK ENDOSCOPY OR OLYMPUS), THE NECROTIC TISSUES WERE REMOVED UNDER DIRECT ENDOSCOPIC GUIDANCE. THE PROCEDURE WAS REPEATED MULTIPLE TIMES DURING EACH NECROSECTOMY SESSION. SUBSEQUENTLY, A NASAL DRAIN AND/OR DOUBLE PIGTAIL PLASTIC STENT WERE INSERTED TRANSMURALLY INTO THE NECROTIC COLLECTION. THE PLACEMENT OF A NASAL DRAIN THROUGH THE LAMS DEVICE IS CONSIDERED OFF LABEL. THIS FILE WILL CONSERVATIVELY CAPTURE THE 71 CASES OF OFF LABEL USE OF THE 7- OR 8-FR NASAL DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2821559 UNKNOWN FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male