BEUDAMED
    FDA Adverse Event Death Summary report: N

    REDIGUARD IAB: 8FR 40CC

    MDR report key: 17843458 · Received September 29, 2023

    Report

    Report Number
    3010532612-2023-00564
    Event Type
    Death
    Date Received
    September 29, 2023
    Date of Event
    September 4, 2023
    Report Date
    October 16, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    00801902002679
    PMA / PMN Number
    K981660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE ADDITIONAL INFORMATION RECEIVED ON 02NOV2023 REPORTED THE DATE OF PATIENT'S DEATH AS (B)(6) 2023 AND THE CAUSE OF DEATH AS CARDIOGENIC SHOCK. THE PATIENT PASSED AWAY PRECISELY 3 DAYS AND 44 HOURS AFTER THE REMOVAL OF THE IAB. THE PATIENT WAS CRITICALLY ILL WITH HIGH SEVERITY AND MORTALITY RATE. AS PER THE PHYSICIAN, THE IAB MIGHT HAVE CONTRIBUTED BUT NOT BEEN THE DIRECT CAUSE OF PATIENT'S DEATH. THE REPORTED COMPLAINT OF IAB KINKED IS CONFIRMED BASED ON THE INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED A 40CC 8.0FR REDIGUARD INTRA-AORTIC BALLOON CATHETER (IABC) WITHOUT THE ORIGINAL PACKAGING FOR INVESTIGATION. THE SAMPLE WAS RETURNED IN THE SUPPLIED RETURN KIT AND WAS IN A SEALED BIO-HAZARD BAG (INP-1, INP-2). UPON RETURN, THE DISTAL END OF THE TEFLON SHEATH WAS NOTED AT APPROXIMATELY 29CM FROM THE IABC DISTAL TIP (INP-4, INP-7). THE TEFLON SHEATH WAS NOTED CONNECTED TO THE HEMOSTASIS CUFF (INP-4). THE ONE-WAY VALVE WAS TETHERED TO THE SHORT DRIVELINE TUBING (INP-5). BENDS TO THE IABC WERE NOTED AT APPROXIMATELY 17.7CM, 39.4CM, AND 42.5CM FROM THE IABC DISTAL TIP (INP-6, INP-8). THE IABC CENTRAL LUMEN WAS NOTED DAMAGED FROM 57.6CM TO 66.0CM FROM THE IABC DISTAL TIP; THE DAMAGES WERE A COMBINATION OF BENDS/KINKS AND A TWISTED APPEARANCE (INP-9 THROUGH INP-12). A HOLE CONSISTENT WITH CONTACT FROM SHARP OBJECT WAS NOTED ON THE CATH-GUARD NEAR THE HEMOSTASIS CUFF (INP-13). DRIED BLOOD WAS NOTED ON THE EXTERIOR SURFACES OF THE RETURNED SAMPLE. NO BLOOD WAS NOTED WITHIN THE HELIUM PATHWAY. THE ONE-WAY VALVE WAS TESTED AND PASSED. A VACUUM WAS PULLED ON THE ONE-WAY VALVE, AND IT HELD FOR AT LEAST 1 MINUTE AND THEN 30 SECONDS FIVE SEPARATE TIMES ACCORDING TO QUALITY SYSTEM DOCUMENT. AN ATTEMPT TO ASPIRATE AND FLUSH THE CATHETER USING A 60CC LAB-INVENTORY SYRINGE WAS UNABLE TO BE SUCCESSFULLY COMPLETED DUE TO A BLOCKED CENTRAL LUMEN. IMMEDIATE PUSH BACK ON THE SYRINGE PLUNGER WAS EXPERIENCED. THE BLOCKAGE WAS MOST LIKELY DRIED BLOOD OR DUE TO THE DAMAGED CENTRAL LUMEN. THE IABC WAS LEAK TESTED IN ACCORDANCE WITH TESTING METHODS FROM MANUFACTURING PROCEDURE. NO LEAKS WERE DETECTED. FULL INFLATION WAS ACHIEVED. THE DEVICE PASSED THE LEAK TEST. A LAB INVENTORY 0.025IN GUIDEWIRE WAS BACK LOADED THROUGH THE IABC DISTAL TIP. THE GUIDEWIRE MET RESISTANCE AND COULD NOT ADVANCE AT APPROXIMATELY 0.1CM FROM THE IABC DISTAL TIP DUE TO A BLOCKED CENTRAL LUMEN. SOME BLOOD WAS NOTED ON THE GUIDEWIRE. THE GUIDEWIRE WAS FRONT LOADED THROUGH THE IABC LUER. RESISTANCE WAS NOTED AT APPROXIMATELY 17.7CM, 18.5CM, AND 19.9CM FROM THE IABC LUER, WHICH ARE THE LOCATIONS OF THE PREVIOUSLY NOTED BENDS/KINKS. THE GUIDEWIRE COULD NOT ADVANCE AT APPROXIMATELY 19.9CM FROM THE IABC LUER. SOME BLOOD WAS NOTED ON THE GUIDEWIRE. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD (DHR), THE PRODUCT MET SPECIFICATION UPON RELEASE; HOWEVER, THE SPECIFICATIONS WERE NOT MET DURING THE COMPLAINT INVESTIGATION DUE TO THE DAMAGED CENTRAL LUMEN. THE ROOT CAUSE OF THE COMPLAINT WAS UNDETERMINED. NO FURTHER ACTION REQUIRED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE PATIENT REQUIRED REPOSITIONING OF THE IABP BECAUSE IT WAS NOT POSITIONED UNDER THE SUBCLAVIAN ARTERY AND ABOVE THE RENAL ARTERIES, AND ITS POSITION COULD NEVER BE ADEQUATELY ADJUSTED. THE BALLOON WAS CLOSELY INSPECTED, AND A TORTUOUS PATH WAS IDENTIFIED IN THE GUIDE WIRE. AS PER MEDICAL RECOMMENDATION, THE DEVICE WAS REMOVED". A 2ND IAB WAS NOT INSERTED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "CRITICAL".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE PATIENT REQUIRED REPOSITIONING OF THE IABP BECAUSE IT WAS NOT POSITIONED UNDER THE SUBCLAVIAN ARTERY AND ABOVE THE RENAL ARTERIES, AND ITS POSITION COULD NEVER BE ADEQUATELY ADJUSTED. THE BALLOON WAS CLOSELY INSPECTED, AND A TORTUOUS PATH WAS IDENTIFIED IN THE GUIDE WIRE. AS PER MEDICAL RECOMMENDATION, THE DEVICE WAS REMOVED". A 2ND IAB WAS NOT INSERTED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "CRITICAL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352971 REDIGUARD IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC 18F22K0060 00801902002679

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Death