BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENT SYSTEM

    MDR report key: 19719178 · Received July 11, 2024

    Report

    Report Number
    3001845648-2024-00363
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    June 13, 2024
    Report Date
    January 23, 2025
    Manufacturer
    COOK MEDICAL IRELAND
    Product Code
    QIJ
    UDI-DI
    00827002465602
    PMA / PMN Number
    DEN180062
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #DEN180062. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION THE DEVICE, CONNECTING TUBE AND TRANSDUCER OF LOT: C2161360 OF ECHO-PPG WAS RETURNED OPENED IN ITS ORIGINAL PACKAGING. THE TRANSDUCER WAS SHIPPED TO THE SUPPLIER FOR INVESTIGATION. THE TRANSDUCER RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION BY THE SUPPLIER CENTURION. THE RETURNED DEVICE LAB FINDINGS AND OBSERVATIONS CAN BE REFERRED THROUGH THE ATTACHED FILE. TRANSDUCER EVALUATION. THE SAMPLE WAS FORWARDED TO CENTURION'S ENGINEERING TEAM, WHO PERFORMED A PRESSURE ACCURACY TEST AND CONFIRMED THE RETURNED SAMPLE WAS ABLE TO MEASURE PRESSURE ACCURATELY FROM 0MMHG TO 900MMHG. THE SAMPLE EVALUATION WAS UNABLE TO CONFIRM THE REPORTED ISSUE. THERE SEEMS TO BE NO EVIDENCE IN THE FILE OF ANY MENTION OF SUCH A KINK. IF THIS KINK WAS NOT OBSERVED BEFORE SHIPPING THE DEVICE BACK TO CIRL THEN IT CAN BE ASSUMED THAT THE KINK WOULD HAVE OCCURRED IN THE TRANSPORT RETURNS PROCESS.¿ REPLY WAS RECEIVED AS FOLLOWS: ¿THE KINK WAS NOT OBSERVED BEFORE THE PROCEDURE, OTHERWISE THE DEVICE WOULD NOT HAVE ZERO¿D PROPERLY. IT LIKELY OCCURRED AFTER THE PROCEDURE.¿. AS PER CUSTOMER CONFIRMATION THE PROXIMAL KINK BELOW THE SHEATH EXTENDER COULD HAVE OCCURRED DURING TRANSPORTATION /DEVICE RETURNS PROCESS. MANUFACTURING RECORDS PRIOR TO DISTRIBUTION, ALL ECHO-PPG DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-PPG OF LOT NUMBER: C2161360 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 WARNINGS SECTION OF THE INSTRUCTIONS FOR USE, IFU0123 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¿, AND THE SYSTEM PREPARATION SECTION: ¿IDENTIFY THE PATIENT¿S PHLEBOSTATIC AXIS AND LEVEL THE TRANSDUCER AT THIS POINT. CAUTION: POSITION THE TRANSDUCER AT THIS LEVEL WHILE OBTAINING THE PRESSURE MEASUREMENTS. ANY MOVEMENT WILL CHANGE CURRENT OR SUBSEQUENT PRESSURE MEASUREMENTS.¿ THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0123) IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS DEFINITIVE ROOT CAUSE WAS ESTABLISHED. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU AND/OR LABEL. AS PER INFORMATION IN DESCRIPTION OF EVENT ¿WHEN MOVING THE MANOMETER, THE NUMBERS WOULD MOVE AROUND.¿ THE COMPLAINT WAS DESCRIBED AS GIVING ERRONEOUS READINGS WHEN THE DEVICE WAS MOVED. THIS IS EXPECTED, THE PHYSIOLOGICAL PRESSURE MAY CHANGE AT DIFFERENT LOCATIONS, OR WHEN THE NEEDLE IS MOVED, THE DEVICE IS MEANT TO BE STATIC, AND READINGS TAKEN WITHOUT THE DEVICE MOVING. USE ERROR COMPLAINTS ARE CONSIDERED FORESEEN MISUSE. IT IS UNKNOWN HOW THE DEVICE WILL PERFORM OUTSIDE OF INSTRUCTIONS FOR USE AND/OR LABELLING REQUIREMENTS. THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU AND/LABEL. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. 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 POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    PER REP - 13JUN2024 - THE DEVICE WAS GIVING SOME ERRONEOUS READINGS FOR THE HEPATIC AND PORTAL PRESSURE. WHEN MOVING THE MANOMETER, THE NUMBERS WOULD MOVE AROUND. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEVICE IN QUESTION.

    Description of Event or Problem · 0

    A SUPPLEMENTAL REPORT BEING SUBMITTED DUE TO COMPLETION OF INVESTIGATION ON 23-JAN-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2379633 ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENT SYSTEM ENDOSCOPIC TRANSHEPATIC VENOUS ACCESS NEEDLE QIJ COOK MEDICAL IRELAND C2161360 00827002465602

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown