BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRANSJUGULAR LIVER ACCESS AND BIOPSY NEEDLE

    MDR report key: 8650812 · Received May 29, 2019

    Report

    Report Number
    1820334-2019-01340
    Event Type
    Death
    Date Received
    May 29, 2019
    Date of Event
    May 14, 2019
    Report Date
    October 18, 2019
    Manufacturer
    COOK INC
    Product Code
    FCG
    UDI-DI
    00827002205475
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. SUFFICIENT CONTROLS ARE IN PLACE TO DETECT POTENTIALLY RELATED FAILURE MODES PRIOR TO RELEASE. THE PRODUCT¿S DESIGN HISTORY FILE WAS REVIEWED AND THE RISKS ASSOCIATED WITH THIS DEVICE WERE ACCEPTABLE WHEN WEIGHTED AGAINST THE BENEFITS. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE COMPLAINT LOT AND RELATED SUBASSEMBLY LOTS SHOWED NO NONCONFORMANCES. A DATABASE SEARCH REVEALED NO OTHER COMPLAINTS UNDER THIS LOT NUMBER AT THE TIME OF THIS INVESTIGATION. SINCE THERE ARE NO NONCONFORMANCES OR OTHER COMPLAINTS FROM THIS LOT, THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. DUE TO LACK OF INFORMATION PROVIDED, NO INSPECTION OF THE RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION, IT WAS CONCLUDED THAT UNINTENDED USE ERROR POSSIBLY CONTRIBUTED TO THE EVENT. INVESTIGATION CONCLUDED IT IS POSSIBLE THAT A BLOOD VESSEL NEAR THE LUNGS WAS PUNCTURED DURING THE NAVIGATION OF THE DEVICE TO THE RENAL VEIN. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    DATE OF DEATH: DATE OF DEATH IS LIKELY (B)(6) 2019. INITIAL REPORTER OCCUPATION: UNKNOWN. PMA/510(K) #: PREAMENDMENT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED A TRANSJUGULAR LIVER ACCESS AND BIOPSY NEEDLE WAS USED IN AN UNKNOWN PATIENT FOR A TRANS-JUGULAR RENAL BIOPSY. IT WAS STATED, ¿PATIENT TRANSFERS (SIC) FROM ANOTHER INSTITUTION FOR A TRANS-JUGULAR RENAL BIOPSY (RIGHT INTERNAL JUGULAR VEIN). AFTER THE PUNCTURE OF THE RIGHT INTERNAL JUGULAR VEIN AND THE INSERTION OF THE SHEATH, THE NEEDLE HAS CROSSED THE SHEATH OF THE APICAL SEGMENT OF THE RIGHT UPPER LOBE. WHEN REMOVING THE BIOPSY NEEDLE, THE PATIENT PRESENTED WITH MASSIVE HAEMOPTYSIS. DESPITE THE INTERVENTION OF THE RESUSCITATORS THE PATIENT DIED.¿ ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444080 TRANSJUGULAR LIVER ACCESS AND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK INC N/A NS9651324 00827002205475

    Patients

    Seq Age Sex Outcome Treatment
    1 Death