BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 18835504 · Received March 5, 2024

    Report

    Report Number
    3001845648-2024-00081
    Event Type
    Injury
    Date Received
    March 5, 2024
    Report Date
    June 14, 2024
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    10827002342818
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K210476 INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K210476. DEVICE EVALUATION. THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. MANUFACTURING RECORDS. PRIOR TO DISTRIBUTION, ALL ECHO-HD-22-EBUS-O-C DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR ECHO-HD-22-EBUS-O-C OF LOT NUMBER C2103713 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. INSTRUCTIONS FOR USE AND/LABEL. AS PER THE INSTRUCTIONS FOR USE, IFU0109 WHICH INFORMS THE USER ABOUT THE POTENTIAL ADVERSE EVENTS "ASSOCIATED WITH BRONCHIAL ENDOSCOPY AND GASTROINTESTINAL 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, SEPTICAEMIA/BACTEREMIA AND TUMOR SEEDING¿. IMAGE REVIEW. AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS. 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 IFU POTENTIAL ADVERSE EVENTS BLEEDING CAN BE COVERED BY ¿HEMORRHAGE¿ AS A KNOWN POTENTIAL ADVERSE EVENT. SUMMARY. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. ACCORDING TO THE INITIAL REPORTER, THE EVENT DID NOT LEAD TO A SERIOUS DETERIORATION IN HEALTH TO THE PATIENT. THE EVENT WAS RESOLVED AT COMPLETION OF DATA COLLECTION. THE SITE INDICATED THAT TREATMENT OF EVENT WAS MEDICAL, AND SPECIFIED ¿LOCAL ANTISTRINGENT AGENTS, ICE WATER, HIGH-FREQUENCY YET VENTILATION, ASPIRATION THERAPY¿. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    AS PER COMPLAINT FORM: THE EVENT TOOK PLACE UNDER THE PROCEDURE. THE SITE DESCRIBED THAT THERE WAS A VASCULAR BLEEDING (HAEMORRHAGE). THE SITE SPECIFIED ¿SEVERE LOCAL BLEEDING FOLLOWING PUNCTURE OF LYMPH NODE 7 (NO SUBMUCOSAL BLOOD VESSELS; NO BLOODY TISSUE SAMPLE)¿. THE SITE INDICATED THAT THE EVENT WAS CONSIDERED TO BE RELATED TO THE COOK EBUS NEEDLE AND ALSO CONSIDERED TO BE RELATED TO ANY PORTION OF THE STUDY PROCEDURE. THE SITE ALSO INDICATED THAT ANOTHER CONDITION DID NOT CAUSE OR CONTRIBUTED TO THIS EVENT. PATIENT OUTCOME: THE EVENT DID NOT LEAD TO A SERIOUS DETERIORATION IN HEALTH TO THE PATIENT. THE EVENT WAS RESOLVED AT COMPLETION OF DATA COLLECTION. THE SITE INDICATED THAT TREATMENT OF EVENT WAS MEDICAL, AND SPECIFIED ¿LOCAL ANTISTRINGENT AGENTS, ICE WATER, HIGH-FREQUENCY YET VENTILATION, ASPIRATION THERAPY¿. SEVERE LOCAL BLEEDING FOLLOWING PUNCTURE OF LYMPH NODE 7 (NO SUBMUCOSAL BLOOD VESSELS; NO BLOODY TISSUE SAMPLE)

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 14-JUN-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166569 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD C2103713 10827002342818

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female