BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW FIBEROPTIX ULTRA 8 IAB SC: 8FR 30CC

    MDR report key: 24096398 · Received January 16, 2026

    Report

    Report Number
    3010532612-2026-00098
    Event Type
    Malfunction
    Date Received
    January 16, 2026
    Date of Event
    December 21, 2025
    Report Date
    December 21, 2025
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    10801902218909
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE SERIAL NUMBER ON THE RETURNED SAMPLE IS (B)(6). RETURNED FOR INVESTIGATION WAS A 30CC 8.0FR FIBEROPTIX ULTRA (SC) INTRA-AORTIC BALLOON CATHETER (IABC) WITHOUT THE ORIGINAL PACKAGING. THE SAMPLE WAS RETURNED IN THE UPS SHIPPING BOX AND WAS IN A SEALED BIO-HAZARD BAG. UPON RETURN, THE SUPPLIED TEFLON SHEATH WAS NOTED ON THE IABC OUTER LUMEN. THE ONE-WAY VALVE WAS TETHERED TO THE SHORT DRIVELINE TUBING. THE IABC 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. UPON RETURN, THE FOS YELLOW JACKET CABLING WAS CUT NEAR THE IAB BIFURCATE. THE REMAINING LENGTH OF THE FOS YELLOW JACKET CABLING INCLUDING THE FOS SC CONNECTOR WAS NOT RETURNED WITH THE 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 QUALITY SYSTEM DOCUMENT. THE FOS CONNECTION WAS UNABLE TO BE TESTED DUE TO THE CUT FOS CABLING. UPON CHECKING THE REMAINING LENGTH OF THE FOS FIBER, NO VISUAL FIBER BREAK WAS NOTED. 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. AN EXTERNAL LEAK WAS IMMEDIATELY DETECTED FROM THE DISTAL END OF THE BIFURCATE BUSHING. UNDER MICROSCOPIC INSPECTION, THE LEAK FROM THE BIFURCATE BUSHING OCCURRED FROM THE ADHESIVE BOND. NO OTHER LEAKS WERE DETECTED. A LAB INVENTORY 0.025IN GUIDEWIRE WAS BACK LOADED THROUGH THE IABC DISTAL TIP. NO RESISTANCE WAS NOTED; 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 "POSSIBLE HE LOSS 2 ALARMS" IS CONFIRMED. DURING THE COMPLAINT INVESTIGATION, AN EXTERNAL HELIUM LEAK WAS CONFIRMED FROM THE INTRA-AORTIC BALLOON CATHETER (IABC) BI-FURCATE BUSHING ADHESIVE, WHICH RESULTED IN THE HELIUM LOSS ALARMS. 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 ADHESIVE. THE PROBABLE ROOT CAUSE IS MANUFACTURING RELATED. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) HAS BEEN INITIATED TO ADDRESS THE ISSUE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    REPORTED AS "POSSIBLE IAB RUPTURE". THE REPORT FURTHER STATES, "[USER] IS CALLING FROM THE CCL. THEY HAVE A PATIENT WITH LEFT MAIN DISEASE WHO THEY HAVE JUST PLACED A 30 CC LWS IAB IN THE R FEM OF A 4 FT 11 IN / 69 KG F PT. APPROXIMATELY 20 MINS AFTER INITIATING THERAPY, THEY RECEIVED 4 POSSIBLE HE LOSS 2 ALARMS. THE PROVIDER IS WONDERING IF THEY SHOULD REPLACE THE IAB. THE IABP IS CURRENTLY PAUSED AND PT IS STABLE. [USER] CONFIRMED THERE WAS NO BLOOD IN DRIVELINE, IAB POSITION LOOKS GOOD ON FLUOROSCOPY, BALLOON IS UNWRAPPED FULLY, AND CONNECTIONS ARE TIGHT. WE DISCUSSED OTHER CAUSES FOR THIS ALARM. THE PHYSICIAN OPTED TO REPLACE THE IAB AT THIS TIME. HE REQUESTED TO CONNECT ON FACETIME FOR CASE SUPPORT. I AGREED. UPON CONNECTION, IAB AND SHEATH REMOVED VIA GUIDEWIRE. ANOTHER 30 CC LWS IAB WAS REPLACED USING THE R FEM. AFTER PLACEMENT, WE DISCUSSED OCCLUSIVITY OF IAB. THE PP WAS 148 AND AUG WAS 106. PHYSICIAN AGREEABLE TO REDUCE VOLUME TO 26 CC". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    REPORTED AS "POSSIBLE IAB RUPTURE". THE REPORT FURTHER STATES, "[USER] IS CALLING FROM THE CCL. THEY HAVE A PATIENT WITH LEFT MAIN DISEASE WHO THEY HAVE JUST PLACED A 30 CC LWS IAB IN THE R FEM OF A 4 FT 11 IN / 69 KG F PT. APPROXIMATELY20 MINS AFTER INITIATING THERAPY, THEY RECEIVED 4 POSSIBLE HE LOSS 2 ALARMS. THE PROVIDER IS WONDERING IF THEY SHOULD REPLACE THE IAB. THE IABP IS CURRENTLY PAUSED AND PT IS STABLE. [USER] CONFIRMED THERE WAS NO BLOOD IN DRIVELINE, IAB POSITION LOOKS GOOD ON FLUOROSCOPY, BALLOON IS UNWRAPPED FULLY, AND CONNECTIONS ARE TIGHT. WE DISCUSSED OTHER CAUSES FOR THIS ALARM. THE PHYSICIAN OPTED TO REPLACE THE IAB AT THIS TIME. HE REQUESTED TO CONNECT ON FACETIME FOR CASE SUPPORT. I AGREED. UPON CONNECTION, IAB AND SHEATH REMOVED VIA GUIDEWIRE. ANOTHER 30 CC LWS IAB WAS REPLACED USING THE R FEM. AFTER PLACEMENT, WE DISCUSSED OCCLUSIVITY OF IAB. THE PP WAS 148 AND AUG WAS 106. PHYSICIAN AGREEABLE TO REDUCE VOLUME TO 26 CC". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164622 ARROW FIBEROPTIX ULTRA 8 IAB SC: 8FR 30CC SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC 18F25K0035 10801902218909

    Patients

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