BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FCG KIT, NEEDLE, BIOPSY

    MDR report key: 9930908 · Received April 6, 2020

    Report

    Report Number
    3001845648-2020-00216
    Event Type
    Injury
    Date Received
    April 6, 2020
    Date of Event
    May 12, 2014
    Report Date
    April 28, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AS EXACT RPN IS UNKNOWN THEN THIS IS THE LIST OF POTENTIAL 510 K #¿S: K160229 OR K142688. PLEASE NOTE, DUE TO LIMITED INFORMATION PROVIDED IN THIS LITERATURE, WE CANNOT CONFIRM OF THE ECHO DEVICES USED, WHICH OF THE FOLLOWING CAUSED THE TWO CASES OF GASTRIC HEMATOMA AT THE SITE OF PUNCTURE, THE FOLLOWING IS A LIST OF POTENTIAL RPN¿S: ECHO-HD-22-EBUS-O ¿ C (K160229) / ECHO-HD-25-EBUS-O ¿ C (K160229) OR ECHO-HD-22-C (K142688) / ECHO-HD-25-C (K142688). AS PER 'MEDICAL DEVICE REPORTING FOR MANUFACTURER'S (2016), SECTION 4.16.2 'SUBMIT AN INDIVIDUAL REPORT FOR EACH DEVICE IDENTIFIED IF THE GENERIC NAMES OF THE DEVICES ARE DIFFERENT.' THEREFORE, ONE REPORT WILL BE SUBMITTED IN RELATION TO THE ABOVE SERIOUS INJURY. DEVICE EVALUATION: THE UNKNOWN DEVICES OF UNKNOWN LOT NUMBERS 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 "LEE ET AL 2014". COMPLAINT FILES (B)(4), (B)(4) AND (B)(4) WERE OPENED AS A RESULT OF THIS PAPER. THIS FILE (B)(4) WAS OPENED TO INVESTIGATE TWO CASES OF GASTRIC HEMATOMA AT THE SITE OF PUNCTURE. DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ECHO DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. AS THE ECHO DEVICES FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. 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. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. AS PER MEDICAL AFFAIRS POTENTIAL COMPLICATIONS INCLUDE HEMATOMA. 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

    TITLE OF LITERATURE: CORE BIOPSY NEEDLE VERSUS STANDARD ASPIRATION NEEDLE FOR ENDOSCOPIC ULTRASOUND-GUIDED SAMPLING OF SOLID PANCREATIC MASSES: A RANDOMIZED PARALLEL-GROUP STUDY - LEE ET AL 2014. STUDY AIMS: WE PROSPECTIVELY COMPARED THE DIAGNOSTIC ACCURACY OF EUS-FNB WITH STANDARD EUSGUIDED FINE NEEDLE ASPIRATION (EUS-FNA) IN PATIENTS WITH SOLID PANCREATIC MASSES. ONE CASE OF MILD BLEEDING AND TWO CASES OF GASTRIC HEMATOMA AT THE SITE OF PUNCTURE WERE IDENTIFIED IN THE FNB GROUP. THIS FILE IS CREATED TO CAPTURE TWO CASES OF GASTRIC HEMATOMA AT THE SITE OF PUNCTURE WERE IDENTIFIED IN THE FNB GROUP. PLEASE NOTE, DUE TO LIMITED INFORMATION PROVIDED IN THIS LITERATURE, WE CANNOT CONFIRM OF THE ECHO DEVICES USED, WHICH OF THE FOLLOWING CAUSED THE TWO CASES OF GASTRIC HEMATOMA AT THE SITE OF PUNCTURE, THE FOLLOWING IS A LIST OF POTENTIAL RPN¿S: ECHO-HD-22-EBUS-O - C / ECHO-HD-25-EBUS-O - C OR ECHO-HD-22-C / ECHO-HD-25-C. AS PER 'MEDICAL DEVICE REPORTING FOR MANUFACTURER'S (2016), SECTION 4.16.2 'SUBMIT AN INDIVIDUAL REPORT FOR EACH DEVICE IDENTIFIED IF THE GENERIC NAMES OF THE DEVICES ARE DIFFERENT.' THEREFORE, ONE REPORT WILL BE SUBMITTED IN RELATION TO THE ABOVE SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. AS EXACT RPN IS UNKNOWN THEN THIS IS THE LIST OF POTENTIAL 510 K #¿S: K160229 OR K142688. PLEASE NOTE, DUE TO LIMITED INFORMATION PROVIDED IN THIS LITERATURE, WE CANNOT CONFIRM OF THE ECHO DEVICES USED, WHICH OF THE FOLLOWING CAUSED THE TWO CASES OF GASTRIC HEMATOMA AT THE SITE OF PUNCTURE, THE FOLLOWING IS A LIST OF POTENTIAL RPN¿S: ECHO-HD-22-EBUS-O ¿ C (K160229) / ECHO-HD-25-EBUS-O ¿ C (K160229) OR ECHO-HD-22-C (K142688) / ECHO-HD-25-C (K142688). AS PER 'MEDICAL DEVICE REPORTING FOR MANUFACTURER'S (2016), SECTION 4.16.2 'SUBMIT AN INDIVIDUAL REPORT FOR EACH DEVICE IDENTIFIED IF THE GENERIC NAMES OF THE DEVICES ARE DIFFERENT.' THEREFORE, ONE REPORT WILL BE SUBMITTED IN RELATION TO THE ABOVE SERIOUS INJURY

    Description of Event or Problem · 1

    TITLE OF LITERATURE: CORE BIOPSY NEEDLE VERSUS STANDARD ASPIRATION NEEDLE FOR ENDOSCOPIC ULTRASOUND-GUIDED SAMPLING OF SOLID PANCREATIC MASSES: A RANDOMIZED PARALLEL-GROUP STUDY - LEE ET AL 2014. STUDY AIMS: WE PROSPECTIVELY COMPARED THE DIAGNOSTIC ACCURACY OF EUS-FNB WITH STANDARD EUSGUIDED FINE NEEDLE ASPIRATION (EUS-FNA) IN PATIENTS WITH SOLID PANCREATIC MASSES. ONE CASE OF MILD BLEEDING AND TWO CASES OF GASTRIC HEMATOMA AT THE SITE OF PUNCTURE WERE IDENTIFIED IN THE FNB GROUP. THIS FILE IS CREATED TO CAPTURE TWO CASES OF GASTRIC HEMATOMA AT THE SITE OF PUNCTURE WERE IDENTIFIED IN THE FNB GROUP. PLEASE NOTE, DUE TO LIMITED INFORMATION PROVIDED IN THIS LITERATURE, WE CANNOT CONFIRM OF THE ECHO DEVICES USED, WHICH OF THE FOLLOWING CAUSED THE TWO CASES OF GASTRIC HEMATOMA AT THE SITE OF PUNCTURE, THE FOLLOWING IS A LIST OF POTENTIAL RPN¿S: ECHO-HD-22-EBUS-O - C / ECHO-HD-25-EBUS-O - C OR ECHO-HD-22-C / ECHO-HD-25-C. AS PER 'MEDICAL DEVICE REPORTING FOR MANUFACTURER'S (2016), SECTION 4.16.2 'SUBMIT AN INDIVIDUAL REPORT FOR EACH DEVICE IDENTIFIED IF THE GENERIC NAMES OF THE DEVICES ARE DIFFERENT.' THEREFORE, ONE REPORT WILL BE SUBMITTED IN RELATION TO THE ABOVE SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391750 FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention