BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUSHING CATHETER

    MDR report key: 17216878 · Received June 28, 2023

    Report

    Report Number
    3001845648-2023-00515
    Event Type
    Malfunction
    Date Received
    June 28, 2023
    Date of Event
    April 19, 2023
    Report Date
    May 31, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002217741
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PMA 510K #K172044 AND K172057. DEVICE EVALUATION: 1 X PC-7 OF LOT NUMBER C1972666 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE DEALS WITH THE KINKING OF THE DEVICE WHICH HAS BEEN ATTRIBUTED TO USER ERROR DUE TO USING AN INCORRECT SIZE WIRE GUIDE. LAB EVALUATION: THE DEVICE LAB EVALUATION COULD NOT BE COMPLETED AS THE DEVICE, OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE, WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL PC-7 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 . A REVIEW OF THE MANUFACTURING RECORDS FOR PC-7 OF LOT NUMBER C1972666 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1972666. IFU REVIEW: IT SHOULD BE NOTED THAT IN THE JAPANESE PACKAGING INSERT (C-ES0202M18): STATES: ¿CHOOSE A WIRE GUIDE WITH OUTER DIAMETER 0.035 INCH (0.89MM) FOR USE WITH THIS PRODUCT". THE JAPANESE PACKAGING INSERT (C-ES0202M18) 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. THERE IS EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE PACKAGING INSERT. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF USER ERROR CAN 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 THE SMALLER DIAMETER 0.025¿ WIRE GUIDE OCCUPIES LESS SPACE IN THE LUMEN OF THE DEVICE USED THIS MAY NOT HAVE SUPPLIED SUFFICIENT SUPPORT WHEN MOVING THE PUSHING CATHETER. AS PER THE ADDITIONAL INFORMATION RECEIVED IT STATED THAT A 0.025" WIRE GUIDE WAS USED. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER/OR REP TESTIMONY. SUMMARY: FAILURE IDENTIFIED: KINK OF PUSHING CATHETER. CONFIRMED QUANTITY OF 1 DEVICE, USED. INVESTIGATION FINDINGS CONCLUDE A DEFINITIVE ROOT CAUSE OF USER ERROR CAN BE ATTRIBUTED TO THE USE OF A NON-RECOMMENDED SIZE WIRE GUIDE WITH THE DEVICE. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ACCORDING TO THE INFORMATION REPORTED, 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

    COMBINED INITIAL AND COMPLETE REPORT BEING SENT DUE TO THE INVESTIGATION BEING COMPLETE IN TIME FOR INITIAL REPORT. THE USER ATTEMPTED BILIARY DORANAGE APPROACHING FROM A DUODENAL PAPILLA VIA ENDOSCOPE. TO PLACE THE STENT, PC-7 WAS ADVANCED OVER WIRE GUIDE, BUT DIDN'T LOAD STEND WELL. THEN HE CHECKED THE PRODUCT AND FOUND THAT THERE WAS A KINK AROUND 10CM FROM THE TIP. THEREFORE HE SELECTED SAME RPN (SAME LOT#) AND COMPLETED THE PROCEDURE. NO HEALTH HAZARD. ADDITIONAL INFORMATION WAS OBTAINED ON (B)(6) 2023. 1 FOR ALL COMPLAINTS, ASK: DOES THE COMPLAINT RELATE TO:DEVICE PLACEMENT/DEVICE REMOVAL/OBSERVATION PRIOR TO PATIENT CONTACT. DEVICE INSERTION. 2 WHAT WAS THE TARGET LOCATION FOR THE STENT? BILIARY TRACT. 3 PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. IT WAS STORED HORIZONTALLY ON THE SHELF. 4 WHAT IS THE REORDER NUMBER, OUTER DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE? OLYMPUS/VISIGLIDE2. 5 WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? YES. 6 WAS THE DEVICE AT THE CENTRE OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? NO. 7 WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? NO, THERE WASN'T ANY DAMAGES. 8 WERE PREVIOUS PROCEDURES I.E. SPHINCTEROTOMY ETC. CARRIED OUT PRIOR TO PLACING THE COMPLAINT DEVICE? YES. 9 IF YES PLEASE INDICATE THE PROCEDURE PERFORMED. CANULATION. 10 DID THE PATIENT INVOLVED EXHIBIT ALTERED ANATOMY OR TORTUOUS ANATOMY? NO. 11 IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? COMPLETED WITH SAME PRODUCT (LOT# UNKNOWN). 12 DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? NO. 13 WHAT INTERVENTION (IF ANY) WAS REQUIRED? 14 WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? 15 WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (OTHER THAN THE REPORTED COMPLAINT ISSUE)? NO. 16 WAS A STRAIGHTENER USED TO STRAIGHTEN THE STENT? 17 (IF ANY DAMAGES WERE CONFIRMED PRIOR TO USE)WAS THE PACKAGE DAMAGED? FOR COMPLAINTS OCCURRING DURING USE (ONCE IN CONTACT WITH ENDOSCOPE) ALSO ASK: 1 HAD A SPHINCTEROTOMY BEEN PERFORMED PRIOR TO THIS OCCURRENCE? NO. 2 WHAT IS THE ENDOSCOPE MANUFACTURER, THE MODEL NUMBER AND WORKING CHANNEL SIZE THAT WAS USED FOR THE PROCEDURE? JF-260V. 3 DOES YOUR MEDICAL FACILITY HAVE A SERVICE/MAINTENANCE SCHEDULE ASSOCIATED WITH ITS ENDOSCOPES? IT SEEMS THAT IT IS PERFORMED BECAUSE I HEARD THAT THE MEDICAL FACILITY IS A MEMBER OF MAINTENANCE. 4 PLEASE INDICATE THE LOCATION IN THE BODY WHERE THE STENT DEVICE WAS TO BE PLACED. I.E. BILIARY DUCT, PANCREATIC DUCT, OTHER. BILIARY TRACT. 6 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE TO THE TARGET LOCATION? NO. 7 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE INTRODUCTION SYSTEM IN PLACE TO THE TARGET LOCATION? NO, THERE WAS NO RESISTANCE. 8 HOW DID THE PHYSICIAN DEAL WITH THIS RESISTANCE? 9 HOW DID THE PHYSICIAN DETERMINE THE LENGTH OF THE STENT TO BE USED FOR THE PROCEDURE? STENOSIS LENGTH WAS MEASURED AND DETERMINED. 10 WHERE WAS THE STRICTURE LOCATED IN THE DUCT? CENTRAL BILE DUCT. 11 WAS THE STRICTURE DILATED PRIOR TO PLACING THE DEVICE? NO. 12 WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE STENT THROUGH THE OBSTRUCTED AREA? NO. 13 AFTER PLACEMENT, WAS STENT POSITION VERIFIED? N/A. 14 IF YES, PLEASE DESCRIBE HOW. FLUOROSCOPY. 15 PLEASE ESTIMATE/INDICATE THE AMOUNT OF TIME THE STENT WAS IN PLACE DWELLING PRIOR TO THIS OCCURRENCE. N/A THIS WAS THE FIRST PLACEMENT. 16 DID ANY SECTION OF THE DEVICE DETACH INSIDE THE ENDOSCOPE OR PATIENT? NO. 17 IF YES, PLEASE SPECIFY WHAT SECTION OF THE DEVICE BROKE OFF: 18 PLEASE INDICATE WHETHER THE DEVICE BROKE IN THE ENDOSCOPE OR IN THE PATIENT? 19 WAS THE BROKEN DEVICE RETRIEVED? N/A. 20 IF YES, PLEASE INDICATE WHAT TOOLS WERE USED DURING RETRIEVAL. 21 WERE ANY MODIFICATIONS MADE TO THE COMPLAINT DEVICE OR ACCESSORIES USED WITH THE DEVICE IN THIS PROCEDURE? ¿ FOR EXAMPLE GUIDING CATHETER SHORTENED. NO. IF YES, PLEASE INDICATE WHAT MODIFICATIONS WERE MADE: PLEASE INDICATE WHY THE MODIFICATIONS WERE NECESSARY. PLEASE INDICATE ANY OTHER ENDOSCOPIC ACCESSORIES (IF ANY) THAT CAME INTO CONTACT WITH THE STENT OR INTRODUCTION SYSTEM DURING THE PROCEDURE. NO OTHER THAN ENDOSCOPY. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS EVENT? NO. WHAT INTERVENTION (IF ANY) WAS REQUIRED? WHAT DOES "INTERVENTION" MEAN? DOES THAT MEANS "PROCEDURE"? WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? WHAT DOES "SECONDARY INTERVENTION" MEAN? DOES THAT MEANS "ADDITIONAL PROCEDURE"? WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (OTHER THAN THE REPORTED COMPLAINT ISSUE)? IF YES, PLEASE SPECIFY WHAT WAS OBSERVED AND WHERE ON THE DEVICE IT WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168537 PUSHING CATHETER FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C1972666 10827002217741

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown