BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENT SYSTEM

    MDR report key: 17412516 · Received July 28, 2023

    Report

    Report Number
    3001845648-2023-00589
    Event Type
    Malfunction
    Date Received
    July 28, 2023
    Report Date
    November 22, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QIJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # DEN180062. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICES WERE NOT RETURNED FOR EVALUATION. THIS FILE WAS CREATED FROM THE ATTACHED PMCF STUDY. THIS FILE (B)(4).WAS OPENED TO INVESTIGATE 3 CASES OF OFF LABEL USE OF ACCESSING THE IVC. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION, ALL ECHO-PPG DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. AS THE LOT NUMBER IS UNKNOWN A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED. INSTRUCTIONS FOR USE AND/LABEL: AS PER THE INSTRUCTIONS FOR USE, IFU0123 WHICH ACCOMPANIES THIS DEVICE, INSTRUCTS THE USER "THE ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENT SYSTEM IS INDICATED TO DIRECTLY MEASURE PRESSURES IN THE HEPATIC AND PORTAL VASCULATURES AND IS USED IN CONJUNCTION WITH AN ULTRASOUND ENDOSCOPE¿. IT MAY BE NOTED THAT THE DEVICE WAS USED OFF-LABEL, AS MEASUREMENTS FOR THREE PATIENTS WERE TAKEN WITHIN THE INTRAHEPATIC PORTION OF THE INFERIOR VENA CAVA DUE TO INABILITY TO ADEQUATELY ACCESS THE HEPATIC VEINS. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS: A DEFINITIVE ROOT CAUSE COULD BE ATTRIBUTED TO OFF LABEL USE. AS PER PMCF STUDY THE DEVICE WAS USED OFF-LABEL, AS MEASUREMENTS FOR THREE PATIENTS WERE TAKEN WITHIN THE INTRAHEPATIC PORTION OF THE INFERIOR VENA CAVA DUE TO INABILITY TO ADEQUATELY ACCESS THE HEPATIC VEINS. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. 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. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 22-NOV-2023.

    Description of Event or Problem · 0

    PORTAL: ENDOSCOPIC ULTRASOUND-GUIDED PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENTS PMCF; GLOBAL CLINICAL NUMBER: 16-03. PROCEDURE: ALL PATIENTS WERE SEDATED FOR THE ENDOSCOPIC ULTRASOUND PORTAL PRESSURE GRADIENT (EUS-PPG) MEASUREMENT PROCEDURE. GENERAL ANESTHESIA WAS USED MOST FREQUENTLY (61.4%, 43/70), AND THE REST OF THE PATIENTS UNDERWENT CONSCIOUS SEDATION OR MONITORED ANESTHESIA CARE (38.6%, 27/70). THE AMOUNT OF TIME THAT THE ENDOSCOPE AND THE ECHOTIP® INSIGHT¿ WERE IN USE IS REPORTED IN TABLE 3.4 1. THE MEAN TOTAL ENDOSCOPE USE TIME FOR THE 25 PATIENTS WHO DID NOT UNDERGO ANY ADDITIONAL PROCEDURES WAS 35.9 ± 10.5 MINUTES; THE MEAN TIME FOR THE 45 PATIENTS WHO UNDERWENT ADDITIONAL PROCEDURES (SEE TABLE 3.4 3) WAS 52.5 ± 25.5 MINUTES. THE MEAN TOTAL USE TIME FOR THE ECHOTIP® INSIGHT¿ WAS 16.7 ± 7.4 MINUTES FOR THE 69 PATIENTS WITH AVAILABLE DATA. TABLE 3.4 2 REPORTS THE SUCCESS OF VENOUS PUNCTURE AND ADDITIONAL DETAILS REGARDING VENOUS ACCESS. HEPATIC VEIN PUNCTURE WAS ACHIEVED IN 95.7% OF CASES (67/70). MEASUREMENTS FOR THREE PATIENTS WERE TAKEN WITHIN THE INTRAHEPATIC PORTION OF THE INFERIOR VENA CAVA DUE TO INABILITY TO ADEQUATELY ACCESS THE HEPATIC VEINS; THIS USE IS CONTRAINDICATED IN THE IFU. AMONG PATIENTS FOR WHOM HEPATIC VEIN PUNCTURE WAS ACHIEVED, A TRANSGASTRIC APPROACH WAS USED FOR HEPATIC VEIN ACCESS IN ALL PATIENTS (100%, 67/67), AND THE MIDDLE HEPATIC VEIN WAS PUNCTURED MOST FREQUENTLY (52.2%, 35/67). PORTAL VEIN PUNCTURE WAS ACHIEVED FOR ALL PATIENTS. A TRANSGASTRIC APPROACH WAS USED FOR PORTAL VEIN ACCESS IN 78.6% OF THE PATIENTS (55/70), AND THE LEFT PORTAL VEIN WAS PUNCTURED MOST FREQUENTLY (88.1%, 59/67). NOTABLY, IN THREE PATIENTS (4.3%, 3/70) THE EXTRAHEPATIC SEGMENT OF THE PORTAL VEIN WAS PUNCTURED; HOWEVER, THE WARNING SECTION OF THE IFU STATES THAT THE VASCULATURE SHOULD BE APPROACHED THROUGH THE LIVER PARENCHYMA TO REDUCE THE RISK OF BLEEDING. ADDITIONAL PROCEDURES WERE PERFORMED DURING THE SAME ENCOUNTER AS THE VENOUS PRESSURE MEASUREMENTS IN 50 OF 70 PATIENTS (71.4%). THESE ADDITIONAL PROCEDURES ARE PRESENTED IN TABLE 3.4 3. SOME SITES CONSIDERED THE EGD AS A SEPARATE PROCEDURE WHILE OTHERS CONSIDERED IT TO BE PART OF THE EUS-PPG PROCEDURE, BUT ALL PATIENTS RECEIVED AN EGD DURING THE EUS-PPG ENCOUNTER. THE MOST COMMON ADDITIONAL PROCEDURE WAS LIVER BIOPSY, PERFORMED IN 42.9% OF THE PATIENTS (30/70), FOLLOWED BY VARICEAL BANDING AND EGD (12.9%, 9/70). THIS FILE WILL CAPTURE THE 3 CASES OF OFF-LABEL USAGE OF ACCESSING THE INFERIOR VENA CAVA (IVC) FOR BELOW PATIENTS: PATIENT ID: (B)(6). LEFT AND MIDDLE HEPATIC VEINS SMALL (2-3MM TARGETS). THEREFORE, INTRAHEPATIC PORTION OF INFERIOR VENA CAVA SELECTED. PATIENT ID: (B)(6). THE HEPATIC VEIN COULD NOT BE ACCESSED; THEREFORE, THE INTRAHEPATIC PORTION OF THE IVC WAS ACCESSED. PATIENT ID: (B)(6). HEPATIC VEIN COULD NOT BE ACCESSED. USED THE INTRAHEPATIC IVC FOR MEASUREMENT. NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337164 ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENT SYSTEM ENDOSCOPIC TRANSHEPATIC VENOUS ACCESS NEEDLE QIJ COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male