BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    MDR report key: 10223447 · Received July 2, 2020

    Report

    Report Number
    3001845648-2020-00384
    Event Type
    Injury
    Date Received
    July 2, 2020
    Date of Event
    March 23, 2018
    Report Date
    May 16, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K142688. DEVICE EVALUATION: THE UNKNOWN DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE. "28 YANG - A PROSPECTIVE RANDOMIZED TRIAL OF EUS-GUIDED TISSUE ACQUISITION¿. DOCUMENTS REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION, ALL ECHO-HD-25-C DEVICES ARE SUBJECTED TO FUNCTIONAL CHECKS AND VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. AS THE LOT NUMBER IS UNKNOWN A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED. AS PER THE INSTRUCTIONS FOR USE, IFU0077-4 WHICH INFORMS THE USER ABOUT THE POTENTIAL COMPLICATIONS "THOSE ASSOCIATED WITH GASTROINTESTINAL ENDOSCOPY INCLUDE, BUT ARE NOT LIMITED TO: PERFORATION, HEMORRHAGE, ASPIRATION, FEVER, INFECTION, ALLERGIC REACTION TO MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST, DAMAGE TO BLOOD VESSELS, NERVE DAMAGE, AND ACUTE PANCREATITIS. THOSE ASSOCIATED WITH EUS NEEDLE BIOPSY INCLUDE BUT ARE NOT LIMITED TO: PAIN, DEATH, PERITONITIS, PORTAL VEIN GAS AND THROMBOSIS, PNEUMOPERITONEUM AND TUMOR SEEDING OF THE NEEDLE TRACT. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. HOWEVER THERE WAS NO EVIDENCE OF A FAILURE REPORTED ASSOCIATED WITH THE ACTUAL DEVICE. AS PER THE IFU POTENTIAL COMPLICATIONS INCLUDE HEMORRHAGE. AS PER MEDICAL AFFAIRS "THE NEEDLE WILL DEFINITELY CAUSE SOME DEGREE OF BLEEDING WHICH IS INHERENT IN THE PROCEDURE. HOWEVER, THE MAJOR BLEEDING INVOLVING BLOOD TRANSFUSION AND ANGIOGRAPHIC EMBOLIZATION WAS LIKELY DUE TO UNINTENDED PUNCTURE". SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT WAS SUCCESSFULLY TREATED WITH A BLOOD TRANSFUSION AND ANGIOGRAPHIC EMBOLIZATION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K142688. DEVICE EVALUATION THE UNKNOWN DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE JOURNAL ARTICLE. "28 YANG - A PROSPECTIVE RANDOMIZED TRIAL OF EUS-GUIDED TISSUE ACQUISITION¿ THIS COMPLAINT FILE WAS OPENED TO INVESTIGATE 1 CASE OF BLEEDING. LAB EVALUATION ¿ N/A. DOCUMENTS REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION, ALL ECHO-HD-25-C DEVICES 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. AS THE LOT NUMBER IS UNKNOWN A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED. AS PER THE INSTRUCTIONS FOR USE, IFU0077-4 WHICH INFORMS THE USER ABOUT THE POTENTIAL COMPLICATIONS "THOSE ASSOCIATED WITH GASTROINTESTINAL ENDOSCOPY INCLUDE, BUT ARE NOT LIMITED TO: PERFORATION, HEMORRHAGE, ASPIRATION, FEVER, INFECTION, ALLERGIC REACTION TO MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST, DAMAGE TO BLOOD VESSELS, NERVE DAMAGE, AND ACUTE PANCREATITIS. THOSE ASSOCIATED WITH EUS NEEDLE BIOPSY INCLUDE BUT ARE NOT LIMITED TO: PAIN, DEATH, PERITONITIS, PORTAL VEIN GAS AND THROMBOSIS, PNEUMOPERITONEUM AND TUMOR SEEDING OF THE NEEDLE TRACT. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW ¿ N/A. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. HOWEVER THERE WAS NO EVIDENCE OF A FAILURE REPORTED ASSOCIATED WITH THE ACTUAL DEVICE. AS PER THE IFU POTENTIAL COMPLICATIONS INCLUDE HEMORRHAGE. AS PER MEDICAL AFFAIRS "THE NEEDLE WILL DEFINITELY CAUSE SOME DEGREE OF BLEEDING WHICH IS INHERENT IN THE PROCEDURE. HOWEVER, THE MAJOR BLEEDING INVOLVING BLOOD TRANSFUSION AND ANGIOGRAPHIC EMBOLIZATION WAS LIKELY DUE TO UNINTENDED PUNCTURE". SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT WAS SUCCESSFULLY TREATED WITH A BLOOD TRANSFUSION AND ANGIOGRAPHIC EMBOLIZATION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K142688. THE UNKNOWN DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE. REFERENCE "28 YANG - A PROSPECTIVE RANDOMIZED TRIAL OF EUS-GUIDED TISSUE ACQUISITION¿ COMPLAINT FILE (B)(4) WAS OPENED TO INVESTIGATE 1 CASE OF BLEEDING WHICH THIS FILE WILL INVESTIGATE. PRIOR TO DISTRIBUTION, ALL ECHO-HD-25-C DEVICES 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. AS THE LOT NUMBER IS UNKNOWN A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED. AS PER THE INSTRUCTIONS FOR USE, WHICH INFORMS THE USER ABOUT THE POTENTIAL COMPLICATIONS "THOSE ASSOCIATED WITH GASTROINTESTINAL ENDOSCOPY INCLUDE, BUT ARE NOT LIMITED TO: PERFORATION, HEMORRHAGE, ASPIRATION, FEVER, INFECTION, ALLERGIC REACTION TO MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST, DAMAGE TO BLOOD VESSELS, NERVE DAMAGE, AND ACUTE PANCREATITIS. THOSE ASSOCIATED WITH EUS NEEDLE BIOPSY INCLUDE BUT ARE NOT LIMITED TO: PAIN, DEATH, PERITONITIS, PORTAL VEIN GAS AND THROMBOSIS, PNEUMOPERITONEUM AND TUMOR SEEDING OF THE NEEDLE TRACT. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. HOWEVER THERE WAS NO EVIDENCE OF A FAILURE REPORTED ASSOCIATED WITH THE ACTUAL DEVICE. AS PER THE IFU POTENTIAL COMPLICATIONS INCLUDE HEMORRHAGE. AS PER MEDICAL AFFAIRS "THE NEEDLE WILL DEFINITELY CAUSE SOME DEGREE OF BLEEDING WHICH IS INHERENT IN THE PROCEDURE. HOWEVER, THE MAJOR BLEEDING INVOLVING BLOOD TRANSFUSION AND ANGIOGRAPHIC EMBOLIZATION WAS LIKELY DUE TO UNINTENDED PUNCTURE". COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE PATIENT WAS SUCCESSFULLY TREATED WITH A BLOOD TRANSFUSION AND ANGIOGRAPHIC EMBOLIZATION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO UPDATE TO F CODE SECTION - SECOND F CODE F23 WAS DELETED.

    Description of Event or Problem · 0

    THIS CORRECTION SUPPLEMENTAL FOLLOW-UP IS BEING SUBMITTED BECAUSE THE COMPLAINT RECORD WAS RE-OPENED SINCE ANNEX A CODE WAS UPDATED FROM A26 TO A24 ON 03-FEB-2022.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER: K142688. INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. [(B)(4)].

    Description of Event or Problem · 1

    TITLE: 'A PROSPECTIVE RANDOMIZED TRIAL OF EUS-GUIDED TISSUE ACQUISITION USING A 25-GAUGE CORE BIOPSY NEEDLE WITH AND WITHOUT A STYLET - YANG ET AL 2018 THE AIMS OF THIS STUDY WERE TO EVALUATE THE FEASIBILITY, SAFETY, AND DIAGNOSTIC YIELD OF A 25-GAUGE CORE BIOPSY NEEDLE WITHOUT (S-) A STYLET AND TO COMPARE ITS PERFORMANCE WITH THAT OF A 25-GAUGE CORE BIOPSY NEEDLE WITH (S+) A STYLET IN PATIENTS WITH SOLID LESIONS ADJACENT TO THE GASTROINTESTINAL TRACT FROM NOVEMBER 2013 TO JANUARY 2016, WE PERFORMED 114 EUS-GUIDED TISSUE ACQUISITIONS FOR THE DIAGNOSIS OF SOLID LESIONS ADJACENT TO THE GASTROINTESTINAL TRACT IN A RANDOMIZED CONTROLLED TRIAL. PATIENTS WERE RANDOMLY ASSIGNED TO THE S+ GROUP (N = 57) OR THE S- GROUP (N = 57). EUS-GUIDED TISSUE ACQUISITION WAS PERFORMED USING A 25-GAUGE CORE BIOPSY NEEDLE 25-GAUGE CORE BIOPSY NEEDLE WITH A REVERSE-BEVEL-SIDED HOLE (ECHOTIP PRO- CORE; COOK IRELAND LTD., LIMERICK, IRELAND) WAS USED FOR EUS-GUIDED TISSUE SAMPLING BLEEDING WAS OBSERVED IN ONE PATIENT IN THE S+ GROUP AND WAS SUCCESSFULLY TREATED WITH A BLOOD TRANSFUSION AND ANGIOGRAPHIC EMBOLIZATION. THIS FILE IS CREATED TO CAPTURE BLEEDING IN ONE PATIENT IN THE S+ GROUP TREATED WITH A BLOOD TRANSFUSION AND ANGIOGRAPHIC EMBOLIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689028 ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention