BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW ULTRAFLEX IAB: 7.5FR 40CC

    MDR report key: 22396924 · Received July 3, 2025

    Report

    Report Number
    3010532612-2025-00613
    Event Type
    Malfunction
    Date Received
    July 3, 2025
    Date of Event
    June 12, 2025
    Report Date
    June 13, 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). THE SERIAL NUMBER ON THE RETURNED SAMPLE IS (B)(6). RETURNED FOR INVESTIGATION WAS A 40CC 7.5FR ULTRAFLEX INTRA-AORTIC BALLOON CATHETER (IABC) WITHOUT THE ORIGINAL PACKAGING BOX. THE SAMPLE WAS RETURNED IN A CARDBOARD BOX AND WAS IN A ZIPLOC BAG. UPON RETURN, THE TEFLON SHEATH WAS NOTED CON-NECTED TO THE HEMOSTASIS CUFF. THE ONE-WAY VALVE WAS TETHERED TO THE SHORT DRIVELINE TUBING. THE BLADDER WAS FULLY UNWRAPPED. DRIED BLOOD WAS NOTED ON THE EXTERIOR SURFACES OF THE RETURNED SAMPLE. NO OBVIOUS BLOOD WAS NOTED WITHIN THE HELIUM PATHWAY. THE CUSTOMER PHOTOS WERE REVIEWED. THE PHOTO SHOWS AN IABC WITH BLOOD ON THE EXTERIOR SURFACE. THE PHOTO SHOWS AN IABP DISPLAY SCREEN WITH A "POSSIBLE HELIUM LOSS 3" ALARM, WHICH IS CONSISTENT WITH THE REPORTED COMPLAINT. 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 QUALITY SYSTEM DOCUMENT. AN ATTEMPT TO ASPIRATE AND FLUSH THE IABC CENTRAL LU-MEN USING A 60CC LAB-INVENTORY SYRINGE WAS UNABLE TO BE SUCCESSFULLY COMPLETED DUE TO A BLOCKED CENTRAL LUMEN. UPON ASPIRATION, WATER WAS UNABLE TO BE PULLED INTO THE SYRINGE. IMMEDIATE PUSH BACK ON THE SYRINGE PLUNGER WAS EXPERIENCED. THE BLOCKAGE WAS MOST LIKELY DRIED BLOOD. THE IABC WAS LEAK TESTED IN ACCORDANCE WITH TESTING METHODS FROM MANUFACTURING PROCEDURE. AN EXTERNAL LEAK WAS IMMEDIATELY NOTED AND LOCATED AROUND THE DISTAL END OF THE BIFURCATE BUSHING ADHESIVE BOND. NO OTH-ER LEAKS WERE DETECTED. A LAB INVENTORY 0.025IN GUIDEWIRE WAS BACK LOADED THROUGH IABC DISTAL TIP. NO RESISTANCE WAS NOTED; THE GUIDEWIRE WAS ABLE TO ADVANCE THROUGH THE CENTRAL LUMEN. SOME BLOOD AND DEBRIS WAS NOTED. AN ATTEMPT TO ASPIRATE AND FLUSH THE CATHETER USING A 60CC LAB-INVENTORY SY-RINGE WAS UNABLE TO BE SUCCESSFULLY COMPLETED BEFORE INSERTING THE GUIDEWIRE. ANOTHER ATTEM PT TO ASPIRATE AND FLUSH THE CATHETER WAS SUCCESSFULLY COMPLETED. 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 "ALARM FOR GAS LEAKAGE" IS CONFIRMED. DURING THE INVESTIGATION, AN EXTERNAL LEAK WAS CONFIRMED FROM THE INTRA-AORTIC BALLOON CATHETER (IABC) BIFURCATE BUSHING ADHESIVE. THE EXTERNAL LEAK COULD CAUSE A HELIUM LOSS ALARM. 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 EXTERNAL LEAK FROM THE IABC BIFURCATE BUSHING. THE PROBABLE ROOT CAUSE OF THE COMPLAINT IS MANUFACTURING RELATED. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) HAS BEEN INITIATED TO FURTHER INVESTIGATE THE ISSUE.

    Additional Manufacturer Narrative · 0

    (B)(4). THE REPORTED COMPLAINT THAT THERE WAS AN "ALARM FOR GAS LEAKAGE" IS CONFIRMED BASED ON THE SUBMITTED PHOTO. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE PHOTO SHOWS AN IABP DISPLAY WITH A "POSSIBLE HELIUM LOSS 3" ALARM. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD (DHR), THE PRODUCT MET SPECIFICATION UPON RELEASE; HOWEVER, THE RECEIVED PRODUCT DID NOT MEET SPECIFICATIONS DUE TO HELIUM LOSS ALARM. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. NO FURTHER ACTION IS 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 "(B)(6) 2025, THE CATHETER INSERTED SUCCESSFUL AND USING NORMAL. THE PUMP GAVE AN ALARM FOR GAS LEAKAGE AND STOPPED THE COUNTER PULSATION. AFTER REPEATED ATTEMPTS WITHOUT IMPROVEMENT, AS THE PATIENT'S CONDITION WAS URGENT, THE DOCTOR DECIDED TO REMOVE THE CATHETER AND CHANGE NEW ONE". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED "ON (B)(6) 2025, THE CATHETER INSERTED SUCCESSFUL AND USING NORMAL. THE PUMP GAVE AN ALARM FOR GAS LEAKAGE AND STOPPED THE COUNTER PULSATION. AFTER REPEATED ATTEMPTS WITHOUT IMPROVEMENT, AS THE PATIENT'S CONDITION WAS URGENT, THE DOCTOR DECIDED TO REMOVE THE CATHETER AND CHANGE NEW ONE". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED " ON (B)(6) 2025, THE CATHETER INSERTED SUCCESSFUL AND USING NORMAL. THE PUMP GAVE AN ALARM FOR GAS LEAKAGE AND STOPPED THE COUNTER PULSATION. AFTER REPEATED ATTEMPTS WITHOUT IMPROVEMENT, AS THE PATIENT'S CONDITION WAS URGENT, THE DOCTOR DECIDED TO REMOVE THE CATHETER AND CHANGE NEW ONE". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1855078 ARROW ULTRAFLEX IAB: 7.5FR 40CC SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC 18F24M0027 00801902026804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.| N/A.