BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW ULTRAFLEX IAB: 7.5FR 30CC

    MDR report key: 18744084 · Received February 20, 2024

    Report

    Report Number
    3010532612-2024-00132
    Event Type
    Malfunction
    Date Received
    February 20, 2024
    Date of Event
    January 22, 2024
    Report Date
    February 6, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    00801902003751
    PMA / PMN Number
    K000729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE REPORTED COMPLAINT THAT THE "BLOOD WAS FOUND IN THE HELIUM LINE" WAS NOT ABLE TO BE CONFIRMED UPON INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED A 30CC 7.5FR ULTRAFLEX INTRA-AORTIC BALLOON CATHETER (IABC) WITHOUT THE ORIGINAL PACKAGING FOR INVESTIGATION. THE SAMPLE WAS RETURNED IN A CARDBOARD BOX AND WAS IN A PLASTIC POUCH (INP-1, INP-2). UPON RETURN, THE IABC BLADDER WAS NOTED WITHDRAWN THROUGH THE TEFLON SHEATH AND THE SHEATH WAS NOTED ON THE IABC BLADDER MEMBRANE (INP-, INP-). THE DISTAL END OF THE TEFLON SHEATH WAS NOTED AT APPROXIMATELY 65.5CM FROM THE IABC LUER END; FLUID/LIQUID BLOOD WAS NOTED WITHIN THE SHEATH SIDEARM (INP-4, INP-6). BUCKING WAS NOTED TO THE TEFLON SHEATH EXTRUSION. FURTHERMORE, THE IABC DISTAL TIP WAS NOTED SEPARATED AND NO LONGER ATTACHED TO THE IABC BLADDER (INP-6, INP-7, AND INP-8). THE BLADDER DETACHMENT AT THIS BOND LIKELY OCCURRED AS A RESULT OF THE BLADDER WITHDRAWAL THROUGH THE TEFLON SHEATH. THE IABC DISTAL TIP WAS NOTED WITHIN THE IABC BLADDER (INP-6, INP-7, AND INP-8). UPON FURTHER INSPECTION, THE IABC DISTAL TIP WAS STILL FULLY INTACT WITH THE CENTRAL LUMEN (INP-6, INP-8). THE ONE-WAY VALVE WAS TETHERED TO THE SHORT DRIVELINE TUBING (INP-5). THE EXPOSED PORTION OF THE BLADDER WAS FULLY UNWRAPPED (INP-6). THE HEMOSTASIS CUFF WAS NOTED DISCONNECTED FROM THE CATH-GUARD (INP-4, INP-9). DAMAGE/BUCKLING TO THE OUTER LUMEN WAS NOTED AT APPROXIMATELY 32CM TO 47.7CM FROM THE IABC LUER END (INP-9). DRIED BLOOD WAS NOTED ON THE EXTERIOR SURFACES OF THE RETURNED IABC. NO OBVIOUS BLOOD WAS NOTED WITHIN THE HELIUM PATHWAY. SINCE THE IABC BLADDER WAS NOTED WITHDRAWN THROUGH THE TEFLON SHEATH AND BUCKLING WAS NOTED TO THE SHEATH EXTRUSION, WHICH INDICATES THE IABC WAS NOT REMOVED FROM THE PATIENT CORRECTLY PER THE INSTRUCTIONS FOR USE (IFU). THE INSTRUCTIONS FOR USE (IFU) STATES: "DO NOT REMOVE ARROW IAB THROUGH HEMOSTASIS SHEATH INTRODUCER OR HEMOSTASIS DEVICE. ONCE UNWRAPPED (UNFURLED), BALLOON PROFILE WILL NOT ALLOW PASSAGE THROUGH THE SHEATH AND ATTEMPTED REMOVAL IN THIS MANNER MAY RESULT IN ARTERIAL TEARING, DISSECTION OR BALLOON DAMAGE." THE BLADDER THICKNESS WAS MEASURED AT SIX POINTS WITH MEASUREMENTS RANGING FROM 0.0057IN-0.0064IN AND WAS WITHIN SPECIFICATION OF PROCESS DOCUMENT. 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 IN ACCORDANCE WITH 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. THE ONE-WAY VALVE WAS CONNECTED TO THE SHORT DRIVELINE TUBING AND VACUUM WAS PULLED ON THE IABC. WHILE MAINTAINING THE VACUUM, THE SHEATH WAS MOVED FROM THE BLADDER AND TOWARDS THE BIFURCATE WITH MINIMAL FORCE REQUIRED. UPON REMOVAL OF THE SHEATH FROM THE IABC BLADDER, AN ADDITIONAL DAMAGE NOTED TO THE IABC OUTER LUMEN; THE IABC OUTER LUMEN WAS NOTED UNRAVELLED AT APPROXIMATELY 50.5CM TO 53CM FROM THE IABC LUER END AND LIKELY OCCURRED DURING THE BLADDER WITHDRAWAL THROUGH THE TEFLON SHEATH (ANP-1). THE IABC BLADDER APPEARED TYPICAL WITH NO VISUAL DAMAGE OR ABNORMALITIES WERE NOTED. THE FURTHER FUNCTIONAL TESTING OF THE RETURNED IABC COULD NOT BE PERFORMED DUE TO THE RETURNED STATE OF THE DEVICE. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD (DHR), THE PRODUCT MET SPECIFICATION UPON RELEASE. THE ROOT CAUSE OF THE COMPLAINT WAS UNDETERMINED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED "AFTER INTUBATION, THE PUMP WAS UNABLE TO DISPLAY ECG SIGNALS AND BLOOD WAS FOUND IN THE HELIUM LINE. THE MACHINE WAS WITHDRAWN AND THE BALLOON WAS WITHDRAWN, AND THE TIP OF THE CENTRAL LUMEN WAS FOUND TO BE SEPARATED FROM THE BALLOON." THE CATHETER WAS REMOVED AND WAS NOT REPLACED. NO PATIENT INJURY OR CONSEQUENCE REPORTED.PATIENT'S CURRENT CONDITION REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED "AFTER INTUBATION, THE PUMP WAS UNABLE TO DISPLAY ECG SIGNALS AND BLOOD WAS FOUND IN THE HELIUM LINE. THE MACHINE WAS WITHDRAWN AND THE BALLOON WAS WITHDRAWN, AND THE TIP OF THE CENTRAL LUMEN WAS FOUND TO BE SEPARATED FROM THE BALLOON." THE CATHETER WAS REMOVED AND WAS NOT REPLACED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. PATIENT'S CURRENT CONDITION REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466142 ARROW ULTRAFLEX IAB: 7.5FR 30CC SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC 18F23J0053 00801902003751

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female