BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW ULTRAFLEX IAB: 7.5FR 40CC

    MDR report key: 23644437 · Received November 25, 2025

    Report

    Report Number
    3010532612-2025-01171
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    October 15, 2025
    Report Date
    October 29, 2025
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    00801902026804
    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). RETURNED FOR INVESTIGATION WAS A 40CC 7.5FR ULTRAFLEX INTRA-AORTIC BALLOON CATHETER (IABC) WITHOUT THE ORIGINAL PACKAGING. THE SAMPLE WAS RETURNED IN A CARDBOARD BOX AND WAS IN A SEALED ZIPLOC BAG. UPON RETURN, THE TEFLON SHEATH WAS NOTED ON THE IABC OUTER LUMEN. THE ONE-WAY VALVE WAS CONNECTED AND TETHERED TO THE SHORT DRIVELINE TUBING. THE IABC BLADDER WAS FULLY UNWRAPPED. THE IABC CENTRAL/OUTER LUMEN WAS NOTED BENT AT APPROXIMATELY 27.8CM FROM THE IABC DISTAL TIP. NO BLOOD WAS NOTED ON THE EXTERIOR SURFACES OF THE RETURNED SAMPLE; THE SAMPLE WAS LIKELY CLEANED EXTERNALLY PRIOR TO ITS RETURN. A SMALL AMOUNT OF DRIED BLOOD WAS NOTED WITHIN THE BLADDER/HELIUM PATHWAY. NO OTHER VISUAL DAMAGE OR ABNORMALITIES WERE NOTED TO THE RETURNED SAMPLE. 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 ACCORDING TO THE QUALITY SYSTEM DOCUMENT. THE IABC CENTRAL LUMEN WAS ASPIRATED AND FLUSHED USING A 60CC LAB-INVENTORY SYRINGE. NO ABNORMALITIES OR DEBRIS WERE NOTED. THE IABC WAS LEAK TESTED IN ACCORDANCE WITH TESTING METHODS FROM MANUFACTURING PROCEDURE. A LEAK WAS IMMEDIATELY DETECTED FROM THE OUTER LUMEN NEAR THE PROXIMAL END OF THE IABC BLADDER AT APPROXIMATELY 31.7CM FROM THE IABC DISTAL TIP. THE LEAK SITES WERE UNABLE TO BE LOCATED UNDER THE MICROSCOPIC INSPECTION. THE CAUSE OF THE LEAK COULD NOT BE CONFIDENTLY DETERMINED. NO LEAKS WERE DETECTED. A LAB INVENTORY 0.025IN GUIDEWIRE WAS BACK LOADED THROUGH THE IABC DISTAL TIP. RESISTANCE WAS NOTED AT APPROXIMATELY 27.7CM FROM THE IABC DISTAL TIP, WHICH IS THE LOCATION OF THE PREVIOUSLY NOTED BEND. THE GUIDEWIRE WAS ABLE TO ADVANCE THROUGH THE CENTRAL LUMEN. NO BLOOD OR DEBRIS WAS NOTED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE REPORTED COMPLAINT FOR "BLOOD LEAKAGE" IS CONFIRMED. DURING THE INVESTIGATION, THE IABC WAS CONFIRMED WITH LEAK FROM THE OUTER LUMEN NEAR THE PROXIMAL END OF THE BLADDER, WHICH ALLOWED BLOOD TO ENTER THE HELIUM PATHWAY. THE CAUSE OF THE DAMAGED OUTER LUMEN COULD NOT BE CONFIDENTLY DETERMINED. 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 OUTER LUMEN LEAK. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. NO FURTHER ACTION REQUIRED AT THIS TIME. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED " THE CATHETER INSERTED INTO THE PATIENT SUCCESSFUL. AFTER ABOUT 3 MINUTES THE PUMP ALARMED THE BALLOON PRESSURE HIGH, AND THE COUNTERPULSATION WAS SUSPENDED. LATER, IT WAS DISCOVERED THAT THERE WAS BLOOD LEAKAGE, SO THE CATHETER WAS REMOVED. CHANGE THE NEW CATHETER". NO PATIENT'S INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED " THE CATHETER INSERTED INTO THE PATIENT SUCCESSFUL. AFTER ABOUT 3 MINUTES THE PUMP ALARMED THE BALLOON PRESSURE HIGH, AND THE COUNTERPULSATION WAS SUSPENDED. LATER, IT WAS DISCOVERED THAT THERE WAS BLOOD LEAKAGE, SO THE CATHETER WAS REMOVED. CHANGE THE NEW CATHETER". NO PATIENT'S INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2601762 ARROW ULTRAFLEX IAB: 7.5FR 40CC SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC 18F24K0121 00801902026804

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male