BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB

    MDR report key: 16471168 · Received March 2, 2023

    Report

    Report Number
    9680794-2023-00202
    Event Type
    Death
    Date Received
    March 2, 2023
    Date of Event
    January 27, 2023
    Report Date
    February 2, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    ALL INFORMATION WAS REPORTED TO TELEFLEX BY THE INITIAL REPORTER IDENTIFIED IN BOX E. IT WAS REPORTED THE GUIDEWIRE WAS FRAYED DURING INSERTION IN THE RIGHT INTERNAL JUGULAR. THE PHYSICIAN NOTED THE WIRE INSERTION WAS DIFFICULT AND FELT STIFF. SHE PULLED IT BACK AFTER NOTING IT DID NOT FEEL RIGHT AND SAW THAT THE COIL HAD UNWOUND IN A SECTION. THE GUIDEWIRE WAS REMOVED IN ITS ENTIRETY AND THE CATHETER WAS PLACED USING ANOTHER KIT IN THE LEFT INTERNAL JUGULAR. NO INTERVENTION WAS NECESSARY OTHER THAN GETTING A NEW KIT. THE PATIENT WAS REPORTED TO BE IN CRITICAL CONDITION PRIOR TO DEVICE USE. IT WAS REPORTED THE PATIENT ULTIMATELY EXPIRED ON (B)(6) 2023 UNRELATED TO THE GUIDEWIRE ISSUE AND THAT POSSIBLE CAUSES OF DEATH WERE GI BLEED, ACUTE ENCEPHALOPATHY, ACUTE HYPOXIC RESPIRATORY FAILURE, NON ST ELEVATION MYOCARDIAL INFARCTION, ACUTE BLOOD LOSS ANEMIA, SHOCK, ACUTE KIDNEY DISEASE, METABOLIC ACIDOSIS, AND ACUTE HRREF.

    Description of Event or Problem · 0

    ALL INFORMATION IN THIS BOX B.5 WAS REPORTED TO TELEFLEX BY THE INITIAL REPORTER IDENTIFIED IN BOX E. IT WAS REPORTED THE GUIDEWIRE WAS FRAYED DURING INSERTION IN THE RIGHT INTERNAL JUGULAR. THE PHYSICIAN NOTED THE WIRE INSERTION WAS DIFFICULT AND FELT STIFF. SHE PULLED IT BACK AFTER NOTING IT DID NOT FEEL RIGHT AND SAW THAT THE COIL HAD UNWOUND IN A SECTION. THE GUIDEWIRE WAS REMOVED IN ITS ENTIRETY AND THE CATHETER WAS PLACED USING ANOTHER KIT IN THE LEFT INTERNAL JUGULAR. NO INTERVENTION WAS NECESSARY OTHER THAN GETTING A NEW KIT. THE PATIENT WAS REPORTED TO BE IN CRITICAL CONDITION PRIOR TO DEVICE USE. IT WAS REPORTED THE PATIENT ULTIMATELY EXPIRED ON (B)(6) 2023 UNRELATED TO THE GUIDEWIRE ISSUE AND THAT POSSIBLE CAUSES OF DEATH WERE GI BLEED, ACUTE ENCEPHALOPATHY, ACUTE HYPOXIC RESPIRATORY FAILURE, NON ST ELEVATION MYOCARDIAL INFARCTION, ACUTE BLOOD LOSS ANEMIA, SHOCK, ACUTE KIDNEY DISEASE, METABOLIC ACIDOSIS, AND ACUTE HRREF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453706 ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB CATHETER,INTRAVASCULAR,THERAPE FOZ ARROW INTERNATIONAL LLC 13F22L0096

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Unknown Death NOT REPORTED| NOT REPORTED