BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEENEN PANCREATIC STENT SET

    MDR report key: 12266474 · Received August 3, 2021

    Report

    Report Number
    3001845648-2021-00593
    Event Type
    Malfunction
    Date Received
    August 3, 2021
    Date of Event
    July 4, 2015
    Report Date
    February 25, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K900923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE GPDS-5-5 STENT OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE JOURNAL ARTICLE. ¿PROPHYLACTIC EFFICACY OF 3- OR 5-CM PANCREATIC STENTS FOR PREVENTING POST-ERCP PANCREATITIS" COMPLAINT FILES (B)(4) WERE OPENED AS A RESULT OF THIS PAPER THIS COMPLAINT 10 CASES OF USER ERROR OF AN INCORRECT SIZED WIREGUIDE USED IN THE FAILED STENTING IN GROUP L. (RPN: GPDS-5-5) (B)(4) (MDR REF 3001845648-2020-00561) CAPTURES THE 2 CASES OF PAPILLARY BLEEDING IN GROUP S. (RPN: GPDS-5-3) (B)(4) (MDR REF 3001845648-2020-00563) CAPTURES THE 2 CASES OF GASTRIC MUCOSAL LACERATIONS IN GROUP L. (RPN: GPDS-5-5) (B)(4) (MDR REF 3001845648-2020-00562) CAPTURES 1 CASE OF PANCREATIC STENT MIGRATION INVOLVING THE GPDS-5-3 STENT. (RPN: GPDS-5-3) (B)(4) (MDR REF 3001845648-2020-00564) CAPTURES 102 CASES OF GROUP L OFF LABEL USE/ FAILED STENTING/INCORRECT WIRE-GUIDE/STENT DISLODGEMENT. (RPN: GPDS-5-3) (B)(4) (MDR REF 3001845648-2020-00565) CAPTURES 110 CASES OF GROUP L OFF LABEL USE/ FAILED STENTING/INCORRECT WIRE-GUIDE/STENT DISLODGEMENT. (RPN: GPDS-5-5) (B)(4) (MDR REF 3001845648-2021-00592) 18 CASES OF USER ERROR OF AN INCORRECT WIREGUIDE WITH THE FAILED PLACEMENT OF THE STENT. (RPN: GPDS-5-3) PRIOR TO DISTRIBUTION ALL GPDS-5-5 DEVICES ARE SUBJECTED TO VISUAL AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE IN CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR THE GPDS-5-5 DEVICE COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. IN THIS STUDY IT WAS REPORTED THAT THERE WAS 240 PATIENTS WHERE STENTS WERE ATTEMPTED TO BE INSERTED FOR THE PREVENT OF POST-ERCP PANCREATITIS. A 0.025" WIRE GUIDE WAS PLACED IN THE PANCREATIC DUCT WHERE THE DEVICES WERE TO BE INSERTED. 10/120 PATIENTS IN GROUP L (5 CM GROUP: GPDS-5-5) EXPERIENCED FAILED STENTING DUE TO DIFFICULT CANNULATION INTO THE PANCREATIC DUCT AND THUS THE STENT WAS NEVER PLACED. AS THE STENTS WOULD NOT BE CONSIDERED OFF-LABEL UNTIL THEY WERE SUCCESSFULLY PLACED THIS FILE IS CAPTURING THE USER ERROR OF THE INCORRECT WIREGUIDE ASSOCIATED WITH THE FAILED PLACEMENT WHILE THE REMAINING 110 CASES WHICH WERE SUCCESSFULLY PLACED, AND THUS USED OFF-LABEL, WILL BE CAPTURED IN (B)(4). THE JAPANESE PACKAGING INSERT (C-ES0202M16) SUPPLIED WITH THE DEVICE COMPLIES WITH MHLW LAW NO. 84 OF 2013 WHICH AVOIDS INCLUDING INFORMATION THAT IS NOT SPECIFIC TO THE MEDICAL DEVICE OR THAT WHICH IS BASIC KNOWLEDGE ALREADY UNDERSTOOD BY THE HEALTHCARE PROFESSIONAL, TO ENSURE TO ACCURATELY CONVEY ALL THE INFORMATION THAT IS IMPORTANT FOR THE USER. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO THE USE OF A NON-RECOMMENDED WIRE GUIDE WITH THE DEVICE. IT MAY BE NOTED THE DEVICE LABEL INDICATES A 0.035¿ WIRE GUIDE FOR USE WITH THIS DEVICE AND ALL SIMULATED USE TESTING TO DATE HAS BEEN COMPLETED USING A 0.035¿ WIRE GUIDE. AS PER INFORMATION REPORTED IN THE PAPER A 0.025" WIREGUIDE WAS USED TO PLACE THE STENT. SUMMARY: COMPLAINT IS BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION REPORTED, THE PATIENTS 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

    THE INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS ON THE (B)(6) 2022.

    Description of Event or Problem · 0

    FUJISAWA ET AL 2016 (GEENEN PANCREATIC STENT) ¿ ¿PROPHYLACTIC EFFICACY OF 3- OR 5-CM PANCREATIC STENTS FOR PREVENTING POST-ERCP PANCREATITIS A PROSPECTIVE, RANDOMIZED TRIAL¿ A TOTAL OF 240 CONSECUTIVE PATIENTS WERE ENROLLED IN THE STUDY AND THE PARTICIPANTS WERE RANDOMLY ASSIGNED TO THE SHORT (3 CM, GROUP S) OR LONG (5 CM, GROUP L) STENT GROUPS. ERCP WAS PERFORMED USING A JF-260V OR TJF-260V DUODENOSCOPE. FIRST, THE ERCP CATHETER SELECTIVELY INSERTED INTO THE MAIN PANCREATIC DUCT, AND A 0.025-INCH GUIDEWIRE WAS PLACED WITH MINIMAL INJECTION OF CONTRAST MEDIUM. THE DOUBLE-WIRED TECHNIQUE WAS USED TO ACCESS THE COMMON BILE DUCT, AND A 0.035-INCH GUIDEWIRE (HYDRAJAGWIRE 5605; BOSTON SCIENTIFIC CORP.) WAS PLACED INTO THE BILE DUCT. AFTER TREATMENT, A 5 FR, UNFLANGED, AND STRAIGHT PPS OF 2 DIFFERENT LENGTHS [3 CM (GPDS-5-3), OR 5 CM (GPDS-5-5), COOK MEDICAL INC., BLOOMINGTON, IN] WAS INSERTED INTO THE PANCREATIC DUCT. 240 PATIENTS WERE DIVIDED INTO GROUPS S (GPDS-5-3) AND GROUP L (GPDS-5-5). THIS FILE ADDRESSES: 120 PATIENTS IN GROUP L WERE INTENDED TO HAVE A PANCREATIC STENT PLACED PROPHYLACTICALLY (OFF LABEL) AND INCORRECT WIREGUIDE, 0.025IN, USED 10 / 120 WHO EXPERIENCED FAILED STENTING IN GROUP L WAS DUE TO DIFFICULT CANNULATION INTO THE PANCREATIC DUCT AND THUS THE STENT WAS NEVER PLACED, AS THESE STENTS WOULD NOT BE CONSIDERED OFF-LABEL UNTIL THEY ARE PLACED, THIS FILE WILL CAPTURE THE USER ERROR FOR THE USE OF AN INCORRECT WIRE GUIDE WITH THEIR FAILED PLACEMENT THE REMAINING 110 PATIENTS ARE CAPTURED IN MDR REF# 3001845648-2020-00565 WHO HAD THE STENT PLACED FOR PROPHYLACTIC USE WHICH IS CONSIDERED OFF-LABEL. THIS COMPLAINT IS CAPTURING THE USER ERROR INCORRECT WIRE GUIDE IDENTIFIED WITHIN THIS PAPER, THIS ISSUE WAS PREVIOUSLY CAPTURED UNDER MDR REF# 3001845648-2020-00565. THERE IS NO CHANGE TO THE DETAILS WHICH WERE PREVIOUSLY SUBMITTED, THIS ADDITIONAL COMPLAINT IS DUE TO COOK IRELAND'S COMPLAINT PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168005 GEENEN PANCREATIC STENT SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown