BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEENEN PANCREATIC STENT

    MDR report key: 19972507 · Received August 13, 2024

    Report

    Report Number
    3001845648-2024-00462
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    April 1, 2018
    Report Date
    September 24, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K900923
    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

    THIS FILE WAS RAISED FROM LITERATURE TO CAPTURE USER ERROR - EXCEEDING INDWELLING TIME OF PANCREATIC STENTS. THIS FILE IS RELATED TO: (B)(4) "JAGIELSKI ET AL 2018 - OFF LABEL USE ¿ WITH BLEEDING." (B)(4) "JAGIELSKI ET AL 2018 - OFF LABEL USE ¿ WITH STENT MIGRATION." (B)(4) "JAGIELSKI ET AL 2018 - OFF LABEL USE." (B)(4) "JAGIELSKI ET AL 2018 - OFF LABEL USE ¿ WITH BLEEDING." (B)(4) "JAGIELSKI ET AL 2018 - OFF LABEL USE." USER/USE RELATED COMPLAINTS IS CONSIDERED FORESEEN MISUSE THEREFORE, IT IS UNKNOWN HOW THE DEVICE WILL PERFORM OUTSIDE OF INSTRUCTIONS FOR USE AND/OR LABELLING REQUIREMENTS. DEVICE EVALUATION: THE UNKNOWN DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. MANUFACTURING RECORDS: AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. PRIOR TO DISTRIBUTION ALL GEPD DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL REVIEW HISTORICAL DATA: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE/LABEL: IT MAY BE NOTED THAT AS PER THE IFU THAT ACCOMPANIES THESE DEVICES, IFU0055, "THIS DEVICE SHOULD NOT BE LEFT INDWELLING FOR MORE THAN THREE MONTHS OR AS DIRECTED BY A PHYSICIAN. PERIODIC EVALUATION IS RECOMMENDED." THERE IS EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. MEDICAL ADVISORS INPUT PROVIDED "USER ERROR - INDWELL PERIOD EXCEEDS 3 MONTHS" IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE USER ERROR OF THE DEVICE EXCEEDING THE RECOMMENDED INDWELL PERIOD OF 3 MONTHS AS PER THE INSTRUCTION FOR USE. AS PER THE IFU THAT ACCOMPANIES THESE DEVICES "THIS DEVICE SHOULD NOT BE LEFT INDWELLING FOR MORE THAN THREE MONTHS OR AS DIRECTED BY A PHYSICIAN. PERIODIC EVALUATION IS RECOMMENDED." USER/USE RELATED COMPLAINTS IS CONSIDERED FORESEEN MISUSE THEREFORE, IT IS UNKNOWN HOW THE DEVICE WILL PERFORM OUTSIDE OF INSTRUCTIONS FOR USE AND/OR LABELLING REQUIREMENTS. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. CORRECTIVE ACTION/CORRECTION: COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS. SUMMARY: FILE WAS CREATED FROM LITERATURE TO CAPTURE USER ERROR - EXCEEDING INDWELLING TIME OF PANCREATIC STENTS. CONFIRMED QUANTITY OF 89 DEVICES, CONFIRMED USED. PATIENT OUTCOME, AS PER INFORMATION PROVIDED NO ADVERSE EFFECTS TO THE PATIENT NOTED IN THIS STUDY. INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE USER ERROR OF THE DEVICE EXCEEDING THE RECOMMENDED INDWELL PERIOD OF 3 MONTHS AS PER THE INSTRUCTION FOR USE. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    JAGIELSKI ET AL 2018 ¿ THE DEVELOPMENT OF ENDOSCOPIC TECHNIQUES FOR TREATMENT OF WALLED-OFF PANCREATIC NECROSIS: A SINGLE-CENTER EXPERIENCE THE STUDY GROUP COMPRISED 101 PATIENTS WITH SYMPTOMATIC WALLED-OFF PANCREATIC NECROSIS WHO UNDERWENT ENDOSCOPIC THERAPY IN OUR DEPARTMENT OVER A 5-YEAR PERIOD FROM 2011 TO 2015. IN ALL PATIENTS, AN ATTEMPT TO PERFORM TRANSMURAL DRAINAGE WAS MADE. THE PLACE OF THE TRANSMURAL TRACT WAS CHOSEN WITH EUS GUIDANCE. GASTROSTOMY(OR DUODENOSTOMY) WAS CREATED WITH THE USE OF GIOVANNINI CYSTOSTOME (CYSTOTOME CST-10, WILSON-COOK). THE FISTULA FORMED BETWEEN THE GASTROINTESTINAL LUMEN AND NECROTIC CAVITY WAS SEQUENTIALLY DILATED WITH AN 8 MM OR 20 MM BALLOON DILATOR (BOSTON SCIENTIFIC). A 7FR OR 8FR NASOCYSTIC DRAIN (BALTON OR WILSON-COOK) AND DOUBLE-PIGTAIL STENTS 7FR OR 8.5FR (ZSO-10-5, WILSON-COOK OR MAR FLOW) WERE DEPLOYED WITHIN THE NECROTIC CAVITY THROUGH THE TRANSMURAL TRACT. WHEN THE MAIN PANCREATIC DUCT LEAK WAS OBSERVED, SPHINCTEROTOMY WAS PERFORMED WITH AN OLYMPUS FLOWCUT KD-301Q0725 SPHINCTEROTOME AND PANCREATIC STENT WAS PLACED (PASSIVE TRANSPAPILLARY DRAINAGE) TO BRIDGE THE LEAK¿5FR, 7FR, 8.5FR, OR 10FR (GEENEN, ZIMMON PANCREATIC STENT, WILSON-COOK MEDICAL INC. OR MAR FLOW) (FIGURES 1(A)¿1(C)). THE STENT WAS THEN REPLACED WITH A NEW ONE AFTER 6, 12, AND 24 MONTHS OR UNTIL THE PANCREATIC DUCT LEAK WAS NO LONGER DEMONSTRATED THIS COMPLAINT WAS OPENED TO CAPTURE USER ERROR - EXCEEDING INDWELLING TIME OF PANCREATIC STENTS. AS PER THE IFU THAT ACCOMPANIES THESE DEVICES, IFU0055-4, "THIS DEVICE SHOULD NOT BE LEFT INDWELLING FOR MORE THAN THREE MONTHS OR AS DIRECTED BY A PHYSICIAN. PERIODIC EVALUATION IS RECOMMENDED." NO ADVERSE EFFECTS TO THE PATIENT NOTED IN THIS STUDY.

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 24-SEP-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1620064 GEENEN PANCREATIC STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown