BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    MDR report key: 10609465 · Received September 30, 2020

    Report

    Report Number
    3001845648-2020-00701
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Date of Event
    September 18, 2016
    Report Date
    October 13, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    PMA / PMN Number
    K083330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE ECHO-25 DEVICES OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE TO CAPTURE ¿28 CASES OF OFF LABEL USE OF ECHO-25 FOR EUS-GUIDED PORTAL PRESSURE GRADIENT MEASUREMENT¿. REFERENCE "HUANG 2017". DOCUMENT REVIEW INCLUDING IFU REVIEW: AS THE ECHO-25 DEVICES ARE FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. PRIOR TO DISTRIBUTION, ALL ECHO-25DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. THE NOTES SECTION OF THE INSTRUCTIONS FOR USE, SE, IFU0101-1, WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER "THIS DEVICE IS USED TO SAMPLE TARGETED SUBMUCOSAL GASTROINTESTINAL LESIONS THROUGH THE ACCESSORY CHANNEL OF AN ULTRASOUND ENDOSCOPE." THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE, A PER PRODUCT MANAGER " ANY PUBLICATIONS PRIOR TO THE FDA CLEARANCE WERE WITH AN ECHO-25 (OFF LABEL USE)." ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD BE DETERMINED FROM THE AVAILABLE INFORMATION. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE USER USED THE DEVICE OFF-LABEL, AS THE ECHO-25 DEVICES WERE USED FOR EUS-GUIDED PORTAL PRESSURE GRADIENT MEASUREMENT, THIS WOULD BE OFF-LABEL USE. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT OUTCOME IS UNKNOWN. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THIS IS A FINAL REPORT. THE INVESTIGATION WAS COMPLETED ON 13-OCT-2020. THE RESULTS AND CONCLUSIONS ARE OUTLINED IN SECTION H OF THIS REPORT. COMPLAINT RECEIVED FROM INTERNAL PERSONNEL VIA E-MAIL ON 10SEP2020--DID 11SEP2020. AS REPORTED TO CUSTOMER RELATIONS: "HUANG, 2017, ECHO-25 AND EUS-GUIDED PORTAL PRESSURE GRADIENT MEASUREMENT WITH A SIMPLE NOVEL DEVICE: A HUMAN PILOT STUDY. HUANG 2017 - ¿28 CASES OF OFF LABEL USE OF ECHO-25 FOR EUS-GUIDED PORTAL PRESSURE GRADIENT MEASUREMENT.¿ AS PER LITERATURE PAPER: ¿EUS-PPGM WAS PERFORMED BY EXPERIENCED ENDOSONOGRAPHERS USING A LINEAR ECHOENDOSCOPE, A 25-GAUGE FINE-NEEDLE ASPIRATION NEEDLE, AND A NOVEL COMPACT MANOMETER.¿ TWENTY-EIGHT PATIENTS UNDERWENT PORTAL PRESSURE MANOMETRY IN THIS STUDY - TWENTY-EIGHT PATIENTS UNDERWENT EUS-PPGM WITH 100% TECHNICAL SUCCESS AND NO ADVERSE EVENTS." THE APPARATUS FOR PPG MEASUREMENT INCLUDED A LINEAR ECHOENDOSCOPE (GF-UC140P-AL5; OLYMPUS), A 25-GAUGE FINE-NEEDLE ASPIRATION (FNA)-NEEDLE (COOK MEDICAL, WINSTON-SALEM, NC), AND A COMPACT MANOMETER WITH NONCOMPRESSIBLE TUBING (COOK MEDICAL, BLOOMINGTON, IND). AS PER IFU0101-1 FOR ECHO-25, THE INTENDED USE IS AS FOLLOWS: THIS DEVICE IS USED TO SAMPLE TARGETED SUBMUCOSAL GASTROINTESTINAL LESIONS THROUGH THE ACCESSORY CHANNEL OF AN ULTRASOUND ENDOSCOPE. THIS FILE IS CREATED TO CAPTURE 28 CASES OF OFF LABEL USE OF ECHO-25 FOR EUS-GUIDED PORTAL PRESSURE GRADIENT MEASUREMENT

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED FROM INTERNAL PERSONNEL VIA E-MAIL ON 10SEP2020--DID 11SEP2020. AS REPORTED TO CUSTOMER RELATIONS: "HUANG, 2017, ECHO-25 AND EUS-GUIDED PORTAL PRESSURE GRADIENT MEASUREMENT WITH A SIMPLE NOVEL DEVICE: A HUMAN PILOT STUDY. HUANG 2017, ¿28 CASES OF OFF LABEL USE OF ECHO-25 FOR EUS-GUIDED PORTAL PRESSURE GRADIENT MEASUREMENT.¿ AS PER LITERATURE PAPER: ¿EUS-PPGM WAS PERFORMED BY EXPERIENCED ENDOSONOGRAPHERS USING A LINEAR ECHOENDOSCOPE, A 25-GAUGE FINE-NEEDLE ASPIRATION NEEDLE, AND A NOVEL COMPACT MANOMETER.¿ TWENTY-EIGHT PATIENTS UNDERWENT PORTAL PRESSURE MANOMETRY IN THIS STUDY - TWENTY-EIGHT PATIENTS UNDERWENT EUS-PPGM WITH 100% TECHNICAL SUCCESS AND NO ADVERSE EVENTS." THE APPARATUS FOR PPG MEASUREMENT INCLUDED A LINEAR ECHOENDOSCOPE (GF-UC140P-AL5; OLYMPUS), A 25-GAUGE FINE-NEEDLE ASPIRATION (FNA)-NEEDLE (COOK MEDICAL, WINSTON-SALEM, NC), AND A COMPACT MANOMETER WITH NONCOMPRESSIBLE TUBING (COOK MEDICAL, BLOOMINGTON, IND). AS PER IFU0101-1 FOR ECHO-25, THE INTENDED USE IS AS FOLLOWS: THIS DEVICE IS USED TO SAMPLE TARGETED SUBMUCOSAL GASTROINTESTINAL LESIONS THROUGH THE ACCESSORY CHANNEL OF AN ULTRASOUND ENDOSCOPE. THIS FILE IS CREATED TO CAPTURE 28 CASES OF OFF LABEL USE OF ECHO-25 FOR EUS-GUIDED PORTAL PRESSURE GRADIENT MEASUREMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070597 ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR