BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE

    MDR report key: 16617937 · Received March 27, 2023

    Report

    Report Number
    3001845648-2023-00185
    Event Type
    Injury
    Date Received
    March 27, 2023
    Date of Event
    October 12, 2021
    Report Date
    May 30, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K)#: K210476. DEVICE EVALUATION: THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICES OR PHOTOGRAPHIC EVIDENCE OF THE DEVICES WAS NOT RETURNED FOR EVALUATION. DOCUMENTS REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-EBUS-O AND ECHO-HD-22-EBUS-P 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 MEDICAL ADVISOR¿S CLINICAL INPUT, MEDIASTINITIS CAN BE COVERED BY ¿INFECTION¿ AS A KNOWN POTENTIAL ADVERSE EVENT. AS PER THE INSTRUCTIONS FOR USE, IFU0051-9 AND IFU0060-5 INFECTION IS A KNOWN ADVERSE EVENT WHICH INFORMS THE USER ABOUT THE POTENTIAL ADVERSE EVENTS "ASSOCIATED WITH BRONCHIAL ENDOSCOPY INCLUDE, BUT ARE NOT LIMITED TO: ALLERGIC REACTION TO MEDICATION, ALLERGIC REACTION TO NICKEL, ASPIRATION, CARDIAC ARRHYTHMIA OR ARREST, DAMAGE TO BLOOD VESSELS, DEATH, DISCOMFORT, FEVER, HEMORRHAGE, HYPOTENSION, INFECTION, INFLAMMATION, NERVE DAMAGE, PAIN, PERFORATION, PNEUMOPERITONEUM, RESPIRATORY DEPRESSION OR ARREST, SEPSIS, SEPTICEMIA/BACTEREMIA AND TUMOR SEEDING¿ THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. THE JAPANESE PACKAGING INSERTS (C-ES1605Y03 AND C-ES1204Y02) SUPPLIED WITH THE DEVICES COMPLY WITH MHLW LAW NO. 84 OF 2013 WHICH AVOIDS INCLUDING INFORMATION THAT IS NOT SPECIFIC TO THE MEDICAL DEVICE OR THAT WHICH IS BASIC KNOWLEDGE ALREADY UNDERSTOOD BY THE HEALTHCARE PROFESSIONAL, TO ENSURE TO ACCURATELY CONVEY ALL THE INFORMATION THAT IS IMPORTANT FOR THE USER. 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. MEDIASTINITIS CAN BE COVERED BY ¿INFECTION¿ AS A KNOWN POTENTIAL ADVERSE EVENT. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ACCORDING TO THE JOURNAL ARTICLE, MEDIASTINITIS OCCURRED IN ONE PATIENT 10 WEEKS AFTER AN EBUS PROCEDURE WITH A STANDARD 22-G NEEDLE, REQUIRING ANTIBIOTICS; NO PROPHYLACTIC ANTIBIOTICS HAD BEEN ADMINISTERED IN THIS PATIENT PRIOR TO THE ENDOSCOPY PROCEDURE. THE PATIENT RECOVERED COMPLETELY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K210476. INVESTIGATION IS STILL PENDING, A FOLLOW-UP MDR REPORT 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 30-MAY-2023.

    Description of Event or Problem · 0

    CROMBAG 2021 - EBUS VERSUS EUS-B FOR DIAGNOSING SARCOIDOSIS: THE INTERNATIONAL SARCOIDOSIS ASSESSMENT (ISA) RANDOMIZED CLINICAL TRIAL. RANDOMIZATION: BOTH ENDOSCOPIC PROCEDURES (EBUS AND EUS-B) WERE PERFORMED USING A LINEAR EBUS SCOPE. PRIOR TO ENDOSCOPY, PATIENTS WERE RANDOMIZED USING WEB-BASED RANDOMIZATION SOFTWARE TO AN ENDOBRONCHIAL (EBUS) OR AN OESOPHAGEAL (EUS-B) APPROACH. IN ADDITION, PATIENTS IN EACH ARM WERE ALSO RANDOMIZED BETWEEN THE STANDARD 22-G NEEDLE (ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE, COOK MEDICAL, LIMERICK, IRELAND) AND THE 25-G BEVEL-TIPPED NEEDLE (ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE, COOK MEDICAL). WE PERFORMED BLOCK RANDOMIZATION STRATIFIED BY CENTRE. ENDOSONOGRAPHY: SEDATION WAS PERFORMED FOLLOWING INSTITUTIONAL PRACTICES; COMMONLY, EITHER DEEP SEDATION WITH PROPOFOL OR MILD SEDATION WITH LOW-DOSE MIDAZOLAM WITH OR WITHOUT OPIOIDS WAS USED. ALL PATIENTS RANDOMIZED TO EBUS UNDERWENT A SYSTEMATIC ENDOSONOGRAPHIC EVALUATION OF ACCESSIBLE MEDIASTINAL/HILAR NODES USING THE EBUS ASSESSMENT TOOL (EBUSAT). FOR PATIENTS RANDOMIZED TO EUS-B, NODES WERE SYSTEMATICALLY ASSESSED USING THE EUS ASSESSMENT TOOL (EUSAT). ENDOSONOGRAPHIC NODAL CHARACTERISTICS WERE SCORED. 1 SERIOUS ADVERSE EVENT: ONE SERIOUS ADVERSE EVENT WAS REPORTED: A PATIENT WITH A FINAL DIAGNOSIS OF SARCOIDOSIS DEVELOPED MEDIASTINITIS 10 WEEKS AFTER AN EBUS PROCEDURE WITH A STANDARD 22-G NEEDLE, REQUIRING ANTIBIOTICS; NO PROPHYLACTIC ANTIBIOTICS HAD BEEN ADMINISTERED IN THIS PATIENT PRIOR TO THE ENDOSCOPY PROCEDURE. THE PATIENT RECOVERED COMPLETELY. THIS FILE CAPTURE THE ABOVE MENTIONED ADVERSE EVENT. PATIENT OUTCOME: THE PATIENT RECOVERED COMPLETELY. PATIENT/EVENT INFO - NOTES: PATIENT INFO: TOTAL PATIENTS = 358. EBUS PROCEDURE: TOTAL PATIENTS = 185, MALE = 112, MEAN AGE = 49 (N = 96 FOR STANDARD 22 G NEEDLE; N = 89 FOR 25 G PROCORE NEEDLE). EUS-B PROCEDURE: TOTAL PATIENTS = 173, MALE = 96, MEAN AGE = 50 (N = 82 FOR STANDARD 22 G NEEDLE; N = 91 FOR 25 G PROCORE NEEDLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835628 ECHOTIP ULTRA ENDOBRONCHIAL HD ULTRASOUND NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention