BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE

    MDR report key: 7013345 · Received November 9, 2017

    Report

    Report Number
    3001845648-2017-00521
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    October 5, 2017
    Report Date
    December 7, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FCG
    UDI-DI
    00827002342811
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K160229. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. INVESTIGATION IS PENDING. A FOLLOW UP MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS,

    Description of Event or Problem · 0

    PNEUMO MEDIASTINAL COMPLICATION 9 HOURS AFTER PROCEDURE ENDED NO BLEEDING DURING THE PROCEDURE. DOCTOR GAVE ME THIS MORNING FOLLOWING INFORMATION : NO PROBLEM MET, NO TECHNICAL DIFFICULTY MET DURING PUNCTION. PROCEDURE STARTED AROUND 8:30AM, ENDED BEFORE 10:00AM. COMPLICATION OCCURRED NEARLY 7:00PM, AS TO SAY 9 HOURS AFTER THE PROCEDURE ENDED. PATIENT REMAINED UNDER FOLLOW UP WITH A POSITIVE AND SPONTANEOUS EVOLUTION. PATIENT HAD A SUBCUTANEOUS EMPHYSEMA. SHE WENT TO NEAREST HOSPITAL EMERGENCY DEPARTMENT, THEN TRANSFERRED TO (B)(6) CENTER. PATIENT HAS BEEN CHECKED "WITH THORACIC" SCAN THEN REMAINED UNDER FOLLOW UP WITH A POSITIVE AND SPONTANEOUS EVOLUTION WITHIN 3 DAYS.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # K160229. (B)(4). EXEMPTION NUMBER: E2016031. IMPORTER SITE CONTACT AND ADDRESS: (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). INVESTIGATION IS STILL PENDING - AWAITING ADDITIONAL CLARIFICATION. A FOLLOW UP MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # K160229. (B)(4). EXEMPTION NUMBER: E2016031 IMPORTER SITE CONTACT AND ADDRESS: (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR RETURN TO COOK. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION; THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE CUSTOMER COMPLAINT IS CONSIDERED TO BE CONFIRMED BASED ON CUSTOMER TESTIMONY. AS PER THE INSTRUCTIONS FOR USE, IFU0109-5 THAT ACCOMPANIES THIS DEVICE, POTENTIAL COMPLICATIONS 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 SEEDLING OF THE NEEDLE TRACT. ON REVIEW OF THE INFORMATION PROVIDED, THERE IS NO VIABLE EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. PRIOR TO DISTRIBUTION, ALL ECHO-HD-25-EBUS-O-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. THE MANUFACTURING RECORDS OF LOT # C1383517 FOR THIS COMPLAINT DID NOT SHOW ANY DISCREPANCIES THAT COULD HAVE ATTRIBUTED TO THIS OCCURRENCE. FROM THE INFORMATION WE HAVE RECEIVED THE PATIENT IS NOW DOING WELL AND HAS HAD NO MORE COMPLICATIONS DUE TO THIS INCIDENT. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    PNEUMO MEDIASTINAL COMPLICATION 9 HOURS AFTER PROCEDURE ENDED NO BLEEDING DURING THE PROCEDURE. DOCTOR GAVE ME THIS MORNING FOLLOWING INFORMATION : NO PROBLEM MET, NO TECHNICAL DIFFICULTY MET DURING PUNCTION. PROCEDURE STARTED AROUND 8:30AM, ENDED BEFORE 10:00AM. COMPLICATION OCCURRED NEARLY 7:00PM, AS TO SAY 9 HOURS AFTER THE PROCEDURE ENDED. PATIENT REMAINED UNDER FOLLOW UP WITH A POSITIVE AND SPONTANEOUS EVOLUTION. PATIENT HAD A SUBCUTANEOUS EMPHYSEMA. SHE WENT TO NEAREST HOSPITAL EMERGENCY DEPARTMENT, THEN TRANSFERRED TO (B)(6). PATIENT HAS BEEN CHECKED WITH THORACIC SCAN THEN REMAINED UNDER FOLLOW UP WITH A POSITIVE AND SPONTANEOUS EVOLUTION WITHIN 3 DAYS.

    Description of Event or Problem · 1

    THIS FOLLOW UP MDR IS BEING SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. PNEUMO MEDIASTINAL COMPLICATION 9 HOURS AFTER PROCEDURE ENDED NO BLEEDING DURING THE PROCEDURE. DOCTOR GAVE ME THIS MORNING FOLLOWING INFORMATION : NO PROBLEM MET, NO TECHNICAL DIFFICULTY MET DURING PUNCTION. PROCEDURE STARTED AROUND 8:30AM, ENDED BEFORE 10:00AM. COMPLICATION OCCURRED NEARLY 7:00PM, AS TO SAY 9 HOURS AFTER THE PROCEDURE ENDED. PATIENT REMAINED UNDER FOLLOW UP WITH A POSITIVE AND SPONTANEOUS EVOLUTION PATIENT HAD A SUBCUTANEOUS EMPHYSEMA. SHE WENT TO NEAREST HOSPITAL EMERGENCY DEPARTMENT, THEN TRANSFERRED TO (B)(6). PATIENT HAS BEEN CHECKED WITH THORACIC SCAN THEN REMAINED UNDER FOLLOW UP WITH A POSITIVE AND SPONTANEOUS EVOLUTION WITHIN 3 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795853 ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK IRELAND LTD G34281 00827002342811

    Patients

    Seq Age Sex Outcome Treatment
    1 Other