BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT

    MDR report key: 19400454 · Received May 27, 2024

    Report

    Report Number
    3001845648-2024-00234
    Event Type
    Malfunction
    Date Received
    May 27, 2024
    Date of Event
    March 11, 2024
    Report Date
    May 22, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QIJ
    UDI-DI
    00827002580008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # DEN180062. DEVICE EVALUATION: 1 UNIT OF LOT C2106666 OF ECHO-PPG-I WAS RETURNED OPENED IN ITS ORIGINAL BOX PACKAGING BUT NOT IN ITS INDIVIDUAL COMPONENT PACKAGING WITHIN THE BOX PACKAGING. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 28 MARCH 2024 AND A RE-EVALUATION ON 29 APR 2024. THE LAB EVALUATION AND RE-EVALUATION NOTES AND LAB ATTENDANCE CAN BE VIEWED IN THE ¿RETURNED PRODUCT ¿ NOTES¿ SECTION. THE NEEDLE HANDLE WAS OBSERVED TO BE DETACHED FROM THE INNER HANDLE. A SEVERE NEEDLE KINK WAS OBSERVED APPROX. 22CM BELOW DISTAL END OF CANNULA WITHIN NEEDLE HANDLE. ATTEMPTED TO REMOVE NEEDLE FROM DEVICE BUT DURING RETRACTION NEEDLE BROKE AT SAME POINT OF SEVERE KINK. RE-ATTACHED NEEDLE HANDLE TO INNER HANDLE WHICH SHOWS LOCATION OF NEEDLE BREAK (PREVIOUSLY SEVERE KINK) TO BE BELOW SHEATH EXTENDER. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL ECHO-PPG-I DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-PPG-I OF LOT NUMBER C2106666 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. REVIEW HISTORICAL DATA: THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR THIS WORK ORDER. INSTRUCTIONS FOR USE AND/LABEL: THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0131 WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO; "VISUALLY INSPECT THE DEVICE WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF A DEVICE ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE¿. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0131). IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO DAMAGE DURING SET UP, INSERTION/ADVANCEMENT DOWN THE SCOPE RESULTING IN THE NEEDLE KINKING BELOW THE SHEATH EXTENDER AS OBSERVED DURING THE LAB EVALUATION. THIS MAY HAVE RESULTED IN THE ISSUE ENCOUNTERED BY THE USER DURING RETRACTION OF THE NEEDLE AND AS RESULT OF THE EXTRA FORCE REQUIRED DURING THE RETRACTION PROCESS MAY HAVE LED TO THE NEEDLE HANDLE DETACHING FROM THE INNER HANDLE. THE KINKED NEEDLE WOULD HAVE MEANT THAT AN ADEQUATE PATHWAY WOULD NOT HAVE BEEN PROVIDED FOR PRESSURE TO BE TRANSMITTED FROM THE PRESSURE SOURCE TO THE COMPASS WHICH WOULD THEN IMPACT THE DISPLAYED PRESSURE AS DETAILED IN THE ANSWER TO Q.16 OF THE STANDARD QUESTIONS. SUMMARY: COMPLAINT IS CONFIRMED BASED ON VISUAL AND/OR FUNCTIONAL INSPECTION. NO PATIENT OUTCOME INFORMATION WAS SHARED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # DEN180062. DEVICE EVALUATION. 1 UNIT OF LOT C2106666 OF ECHO-PPG-I WAS RETURNED OPENED IN ITS ORIGINAL BOX PACKAGING BUT NOT IN ITS INDIVIDUAL COMPONENT PACKAGING WITHIN THE BOX PACKAGING. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 28 MARCH 2024 AND A RE-EVALUATION ON 29 APR 2024. THE NEEDLE HANDLE WAS OBSERVED TO BE DETACHED FROM THE INNER HANDLE. A SEVERE NEEDLE KINK WAS OBSERVED APPROX. 22CM BELOW DISTAL END OF CANNULA WITHIN NEEDLE HANDLE. ATTEMPTED TO REMOVE NEEDLE FROM DEVICE BUT DURING RETRACTION NEEDLE BROKE AT SAME POINT OF SEVERE KINK. RE-ATTACHED NEEDLE HANDLE TO INNER HANDLE WHICH SHOWS LOCATION OF NEEDLE BREAK (PREVIOUSLY SEVERE KINK) TO BE BELOW SHEATH EXTENDER. MANUFACTURING RECORDS. PRIOR TO DISTRIBUTION, ALL ECHO-PPG-I DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-PPG-I OF LOT NUMBER C2106666 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. REVIEW HISTORICAL DATA. THE REVIEW OF RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED FOR THIS WORK ORDER. INSTRUCTIONS FOR USE AND/LABEL. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, IFU0131 WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO; "VISUALLY INSPECT THE DEVICE WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF A DEVICE ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE¿. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0131). IMAGE REVIEW. AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS. A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO DAMAGE DURING SET UP, INSERTION/ADVANCEMENT DOWN THE SCOPE RESULTING IN THE NEEDLE KINKING BELOW THE SHEATH EXTENDER AS OBSERVED DURING THE LAB EVALUATION. THIS MAY HAVE RESULTED IN THE ISSUE ENCOUNTERED BY THE USER DURING RETRACTION OF THE NEEDLE AND AS RESULT OF THE EXTRA FORCE REQUIRED DURING THE RETRACTION PROCESS MAY HAVE LED TO THE NEEDLE HANDLE DETACHING FROM THE INNER HANDLE. THE KINKED NEEDLE WOULD HAVE MEANT THAT AN ADEQUATE PATHWAY WOULD NOT HAVE BEEN PROVIDED FOR PRESSURE TO BE TRANSMITTED FROM THE PRESSURE SOURCE TO THE COMPASS WHICH WOULD THEN IMPACT THE DISPLAYED PRESSURE AS DETAILED IN THE ANSWER TO Q.16 OF THE STANDARD QUESTIONS. SUMMARY. COMPLAINT IS CONFIRMED BASED ON VISUAL AND/OR FUNCTIONAL INSPECTION. NO PATIENT OUTCOME INFORMATION WAS SHARED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 22-MAY-2024.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT: HANDLE FELL OFF DEVICE. UPDATED AS PER COMPLAINT FOR RECEIVED ON 13/3/24 (B)(4): THE PPG HAD BEEN PERFORMED IN THE HEPATIC VEIN. WHEN THE NEEDLE HANDLE WAS PULLED BACK TO REPOSITION INTO THE PORTAL VEIN THE HANDLE COMPLETELY CAME OFF THE SYSTEM. THE PROCEDURE WAS FINISHED WITH AN ALTERNATE NEEDLE. PATIENT OUTCOME: UPDATED AS PER COMPLAINT FORM RECEIVED ON 13/3/24 (B)(4). PATIENT/EVENT INFO - NOTES: REPLY FROM THE REP WAS RECEIVED ON 24/4/24 (B)(4). CAN YOU PLEASE CLARIFY THE FOLLOWING IN RELATION TO THIS ANSWER; - DOES THE ¿DEVICE¿ MEAN THE TRANSDUCER? YES. - IF IT IS THE TRANSDUCER AT WHAT STAGE OF THE PROCEDURE DID THE USER OBSERVED THAT IT WAS NOT DISPLAYING ACCURATE NUMBERS? THE NUMBERS ON THE TRANSDUCER APPEARED TO BE INACCURATE FROM THE BEGINNING ON THE PROCEDURE. REPLY FROM THE REP WAS RECEIVED ON 15/4/24 (B)(4): ¿ ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? N/A, YES, NO NO. 2. IDENTIFY WHICH DEVICE. 3. IF THE REPORT INVOLVES A KINK OR BEND IN THE NEEDLE, WHERE IS THIS LOCATED ON THE DEVICE (HANDLE END (PROXIMAL END) OR PATIENT END (DISTAL END))? N/A, HANDLE END, PATIENT END N/A. A. IF THE DEVICE WAS KINKED BELOW THE SHEATH EXTENDER, WAS THE KINK OBSERVED BEFORE INSERTING THE DEVICE INTO THE SCOPE? N/A, YES, NO N/A. 4. WAS THE DEVICE DAMAGED IN PACKAGING PRIOR TO REMOVAL? N/A, YES, NO NO. 5. WAS THE DEVICE DAMAGED ON REMOVAL FROM PACKAGING? N/A, YES, NO NO. 6. WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? N/A, YES, NO NO. 7. WAS THE DEVICE USED IN A TORTUOUS POSITION? N/A, YES, NO NO. 8. WAS PUNCTURE OF THE TARGET SITE DIFFICULT? N/A, YES, NO NO. 9. PLEASE ADVISE THE ANATOMICAL LOCATION OF THE INTENDED TARGET SITE (PORTAL VEIN, HEPATIC VEIN ETC.) PORTAL VEIN. 10. WHERE WAS THE VESSEL TARGETED FROM? OGJ. 11. DID THE NEEDLE PASS THROUGH THE LIVER PARENCHYMA? YES. 12. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE PERFORMED AND/OR FINISHED? A NEW DEVICE. 13. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES? N/A, YES, NO NO.. 14. WAS ANY SECONDARY INTERVENTION REQUIRED?NO. 15. WAS THE SECONDARY INTERVENTION PERFORMED DURING THE SAME PROCEDURE AS THE DEVICE FAILURE OR WAS IT SCHEDULED FOR ANOTHER DAY? N/A, SAME PROCEDURE, ANOTHER DAY. 16. WERE ANY OTHER DEFECTS OBSERVED ON THE DEVICE PRIOR TO RETURN (E.G. KINKS, BENDS, BREAKS ETC.)? N/A, YES, NO THE DEVICE WAS NOT DISPLAYING ACCURATE NUMBERS. 17. IF YES, PLEASE SPECIFY WHAT WAS OBSERVED AND WHERE ON THE DEVICE IT WAS OBSERVED. 18. IS IT KNOWN IF THE PATIENT RECENTLY TESTED POSITIVE FOR COVID-19? N/A, YES, NO NA. 19. IF YES, PLEASE DO NOT RETURN THE COMPLAINT DEVICE TO CIRL FOR EVALUATION. PLEASE TAKE PICTURES OF THE DEFECT WHERE POSSIBLE AND PROVIDE THESE TO AID THE INVESTIGATION. 20. DID THE TRANSDUCER DISPLAY A SOFTWARE ERROR CODE? YES/NO NO. A. IF YES WHAT CODE? 21. ESTIMATED TIME FOR TRANSDUCER TO STABILIZE? 1 MINUTE. 22. WERE AIR BUBBLES IDENTIFIED WITHIN THE SYSTEM? NO. 23. WAS FLUID IDENTIFIED LEAKING FROM THE CONNECTORS? NO. FOR COMPLAINTS OCCURRING DURING USE (ONCE IN CONTACT WITH SCOPE) ALSO ASK: 1. WHAT IS THE SCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED?OLYMPUS LINEAR EUS SCOPE. 2. WAS RESISTANCE FELT WHILE INSERTING THE DEVICE THROUGH THE SCOPE? N/A, YES, NO. 3. WAS THE SCOPE RECENTLY SERVICED / REPAIRED? N/A, YES, NO. 4. WHEN WAS THE ISSUE WITH THE PRODUCT NOTED? E.G. ON ADVANCEMENT OF THE SHEATH/NEEDLE OR ON NEEDLE RETRACTION? ADVANCEMENT OF SHEATH, RETRACTION OF NEEDLE. 5. WAS DIFFICULTY EXPERIENCED WHILE RETRACTING THE NEEDLE? N/A, YES, NO. 6. WAS IT POSSIBLE TO FULLY RETRACT THE NEEDLE INTO THE SHEATH BEFORE REMOVING THE DEVICE FROM THE PATIENT? N/A, YES, NO THE HANDLE FULLY DISCONNECTED FROM THE DEVICE. 7. WAS THE SCOPE IN A FLEXED OR TWISTED POSITION AT ANY TIME DURING THE PROCEDURE? N/A, YES, NO. 8. HOW MANY TIMES WAS VESSELS ACCESSED WITH THIS NEEDLE? 2. 9. DID ANY SECTION OF THE DEVICE DETACH INSIDE THE PATIENT? N/A, YES, NO. IF SO, PLEASE SPECIFY: _____________________. 10. WAS THERE DIFFICULTY LOCKING THE SHEATH (OR NEEDLE) IN PLACE OR WAS SLIPPING EXPERIENCED DURING USE? N/A, YES, NO. 11. WAS THERE ANY DIFFICULTY ATTACHING OR DETACHING THE DEVICE TO THE ACCESSORY CHANNEL PORT ON THE SCOPE? N/A, YES, NO. 12. WHEN THE NEEDLE TIP WAS ADVANCED INTO THE TARGET SITE WAS THE DISTAL SCOPE POSITION ADJUSTED SO AS TO STRAIN OR FLEX THE NEEDLE? N/A, YES, NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398837 ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT ENDOSCOPIC TRANSHEPATIC VENOUS ACCESS NEEDLE QIJ COOK IRELAND LTD C2106666 00827002580008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male