BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENT SYSTEM

    MDR report key: 17225570 · Received June 29, 2023

    Report

    Report Number
    3001845648-2023-00507
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Date of Event
    April 17, 2023
    Report Date
    October 5, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QIJ
    UDI-DI
    00827002465602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT CODE QIJ PMA 510K # (B)(4). DEVICE EVALUATION 1 UNIT OF LOT C1999588 OF ECHO-PPG WAS RETURNED OPENED IN ITS ORIGINAL PACKAGING. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION A PROXIMAL KINK BELOW THE SHEATH EXTENDER WAS OBSERVED. THE NEEDLE WAS UNABLE TO ADVANCE OR RETRACT. 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 C1999588 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, 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¿. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE ((B)(4)). 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 LEADING TO THE RESULTING DIFFICULTY WITH THE NEEDLE ADVANCING. SUMMARY COMPLAINT IS CONFIRMED BASED ON VISUAL AND/OR FUNCTIONAL INSPECTION. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    SUPPLEMENT REPORT BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON (B)(6) 2023.

    Description of Event or Problem · 0

    REPORTED BY THE DM ON BEHALF OF THE CUSTOMER VIA EMAIL - YESTERDAY DURING A EUS PROCEDURE WHICH THE PHYSICIAN WAS TRYING TO ATTAIN A PORTAL PRESSURE GRADIENT AND THEY COULDN¿T ADVANCE THE NEEDLE FROM THE SCOPE. THE PATIENT WAS NEVER PUNCTURED WITH THIS DEVICE AND THEY REMOVED SCOPE FROM PATIENT AND TRIED TO ADVANCE NEEDLE IN WHICH IT REMAINED UNSUCCESSFUL. WE SWITCH TO A NEW DEVICE NEEDLE AND THE CASE WAS SUCCESSFULLY COMPLETED. THE FOLLOWING HAS BEEN REQUESTED- JM (B)(6)2023: DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? IF YES, PLEASE DESCRIBE. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE THIS OCCURRENCE? THE FOLLOWING HAS BEEN ANSWERED- JM (B)(6)2023 DID ANY UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? NO IF YES, PLEASE DESCRIBE. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE? NO DID THE PRODUCT CAUSE OR CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURES? NO IF YES, PLEASE SPECIFY ADDITIONAL PROCEDURES AND PROVIDE DETAILS. HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? NO HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? NO PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. WAS THE PATIENT HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE THIS OCCURRENCE? NO, NEW WAS USED AND PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER VERIFICATION, NO ADDITIONAL MANUFACTURER QUESTIONS APPLY TO THIS GPN/RPN. JM (B)(6)2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254525 ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENT SYSTEM ENDOSCOPIC TRANSHEPATIC VENOUS ACCESS NEEDLE QIJ COOK IRELAND LTD G46560 C1999588 00827002465602

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown