BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW FIBEROPTIX ULTRA 8 IAB: 8FR 50CC

    MDR report key: 18672492 · Received February 8, 2024

    Report

    Report Number
    3010532612-2024-00109
    Event Type
    Malfunction
    Date Received
    February 8, 2024
    Date of Event
    January 28, 2024
    Report Date
    January 28, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE REPORTED COMPLAINT OF IAB FOS WOULD NOT ZERO WAS CONFIRMED UPON INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED A 50CC 8.0FR FOS 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). RETURNED WITH THE SAMPLE WAS THE 50CC INFLATION DRIVELINE TUBING; SOME DRIED BLOOD WAS NOTED ON THE EXTERIOR OF THE TUBING (INP-4). NO BLOOD WAS NOTED WITHIN THE DRIVELINE TUBING AND NO ABNORMALITIES WERE NOTED TO THE TUBING. UPON RETURN, THE DISTAL END OF THE TEFLON SHEATH WAS AT APPROXIMATELY 26.7CM FROM THE IABC DISTAL TIP (INP-4). THE SIDEARM FOR THE SHEATH WAS NOTED CUT NEAR THE SHEATH HUB AND THE SHEATH SIDEARM WAS NOT RETURNED WITH THE SAMPLE (INP-6). THE ONE-WAY VALVE WAS TETHERED TO THE SHORT DRIVELINE TUBING (INP-5). THE BLADDER WAS FULLY UNWRAPPED (INP-7). BENDS WERE NOTED TO THE IABC AT APPROXIMATELY 49.0CM AND 56.0CM FROM THE IABC DISTAL TIP (INP-8, INP-9). DRIED BLOOD WAS NOTED ON THE EXTERIOR SURFACES OF THE RETURNED IABC. NO BLOOD WAS NOTED WITHIN THE HELIUM PATHWAY. UPON RETURN, THE YELLOW FOS CABLING WAS NOTED CUT NEAR THE IABC BIFURCATE (INP-5 AND INP-10). THE FOS CONNECTOR, CAL KEY, AND SOME OF THE FOS CABLE WERE RETURNED WITH THE SAMPLE (INP-5). THE FOS CONNECTOR AND CAL KEY WERE EXAMINED. THE FOS GRAY CONNECTOR WAS PROPERLY SEATED IN THE BLUE CLAMSHELL HOUSING AND BOTH RETAINING TABS WERE INTACT (INP-11, INP-12, AND INP-13). THE CENTER POST OF THE FOS WAS CENTERED. THE BLUE CLAMSHELL HOUSING WAS EXAMINED, AND NO ABNORMALITIES WERE NOTED. THE CAL KEY WAS INTACT. THE CAL KEY WAS EXAMINED, AND NO DAMAGE WAS NOTED (INP-14, INP-15). THE CAL KEY CODE IS "LCS" (INP-14). 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. THE CAL KEY AND FOS WERE CONNECTED TO THE IABP. THE CAL KEY WAS RECOGNIZED (ANP-1). THE CAL KEY WAS DISCONNECTED AND RE-CONNECTED AGAIN AFTER ROTATING THE CAL KEY 180 DEGREES; THE CAL KEY WAS RECOGNIZED AGAIN. THE PUMP STATUS DISPLAYED "LL" LOW LIGHT AND "PL" PRESSURE LIMIT, INDICATING A POSSIBLE BROKEN FIBER (ANP-2). UPON CHECKING THE REMAINING LENGTH OF THE FOS FIBER, THE FIBER WAS CONFIRMED BROKEN APPROXIMATELY 26.5CM FROM THE IABC BLADDER TIP (ANP-3). NO OTHER FIBER BREAKS WERE NOTED. THE IABC CENTRAL LUMEN WAS SUCCESSFULLY ASPIRATED AND FLUSHED USING A 60CC LAB-INVENTORY SYRINGE. SOME BLOOD WAS NOTED. 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. RESISTANCE WAS NOTED AT APPROXIMATELY 49.0CM AND 56.2CM FROM THE IABC DISTAL TIP, WHICH ARE THE LOCATIONS OF THE PREVIOUSLY NOTED BENDS. THE GUIDEWIRE WAS ABLE TO ADVANCE THROUGH THE CENTRAL LUMEN. NO BLOOD OR DEBRIS WAS NOTED. THE GUIDEWIRE WAS FRONT LOADED THROUGH THE IABC LUER. RESISTANCE WAS NOTED AT APPROXIMATELY 26.2CM AND 33.3CM FROM THE IABC LUER, WHICH ARE THE LOCATIONS OF THE PREVIOUSLY NOTED BENDS. THE GUIDEWIRE WAS ABLE TO ADVANCE THROUGH THE CENTRAL LUMEN. NO BLOOD OR DEBRIS WAS NOTED. 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 BROKEN FIBER. THE ROOT CAUSE OF THE BROKEN FIBER IS UNDETERMINED. NO FURTHER ACTION REQUIRED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "FAILED FOS". IAB WAS REMOVED AND REPLACED TO COMPLETE TREATMENT. FURTHER INFORMATION STATES THE USER CALLED FOR ASSISTANCE WITH NO SIGNAL FROM THE FOS. THE USER STATED THAT THEY JUST PLACED THE IAB THERE IN THE OR. THE USER DOES NOT RECALL HEARING ANY TONES WHEN THE FOS SENSOR WAS CONNECTED. AFTER THE IAB WAS INSERTED, THE USER STATED THAT THERE WAS NO SIGNAL FROM THE FOS NOR FROM THE TRANSDUCER THAT WAS CONNECTED TO THE CENTRAL LUMEN. A SECOND IAB WAS INSERTED WITHIN THE SAME INSERTION SITE AND WAS SUCCESSFUL. NO PATIENT INJURY OR CONSEQUENCE REPORTED. PATIENT'S CONDITION REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "FAILED FOS". IAB WAS REMOVED AND REPLACED TO COMPLETE TREATMENT. FURTHER INFORMATION STATES THE USER CALLED FOR ASSISTANCE WITH NO SIGNAL FROM THE FOS. THE USER STATED THAT THEY JUST PLACED THE IAB THERE IN THE OR. THE USER DOES NOT RECALL HEARING ANY TONES WHEN THE FOS SENSOR WAS CONNECTED. AFTER THE IAB WAS INSERTED, THE USER STATED THAT THERE WAS NO SIGNAL FROM THE FOS NOR FROM THE TRANSDUCER THAT WAS CONNECTED TO THE CENTRAL LUMEN. A SECOND IAB WAS INSERTED WITHIN THE SAME INSERTION SITE AND WAS SUCCESSFUL. NO PATIENT INJURY OR CONSEQUENCE REPORTED. PATIENT'S CONDITION REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68238 ARROW FIBEROPTIX ULTRA 8 IAB: 8FR 50CC SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC 18F23K0006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male AC3 OPTIMUS| AC3 OPTIMUS