BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX IAB: 7.5FR 40CC

    MDR report key: 17342791 · Received July 18, 2023

    Report

    Report Number
    3010532612-2023-00391
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Date of Event
    June 26, 2023
    Report Date
    June 26, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    10801902145731
    PMA / PMN Number
    K000729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE REPORTED COMPLAINT OF "BALLOON DID NOT FULLY UNWRAP" WAS NOT CONFIRMED BASED ON THE RETURNED SAMPLE. THE CUSTOMER RETURNED A 40CC 8.0FR FOS INTRA-AORTIC BALLOON CATHETER (IABC) WITHOUT THE ORIGINAL PACKAGING FOR INVESTIGATION. THE SAMPLE WAS RETURNED IN A CARDBOARD BOX AND WAS IN A SEALED BIOHAZARD BAG (INP-1, INP-2). UPON RETURN, THE DISTAL END OF THE TEFLON SHEATH WAS NOTED AT APPROXIMATELY 35.3CM FROM THE IABC DISTAL TIP; LIQUID BLOOD WAS NOTED WITHIN THE SHEATH SIDEARM (INP-4). THE ONE-WAY VALVE WAS TETHERED TO THE SHORT DRIVELINE TUBING (INP-5). THE SUPPLIED 40CC INFLATION DRIVELINE TUBING WAS NOTED CONNECTED TO THE IABC SHORT DRIVELINE TUBING; NO DAMAGE OR ABNORMALITIES WERE NOTED TO THE INFLATION DRIVELINE TUBING (INP-4, INP-5). THE IABC BLADDER WAS FULLY UNWRAPPED, AND NO ABNORMALITIES WERE NOTED TO THE IABC BLADDER (INP-6). DRIED BLOOD WAS NOTED ON THE EXTERIOR SURFACES OF THE RETURNED IABC. NO BLOOD WAS NOTED WITHIN THE HELIUM PATHWAY. UPON RETURN, IT WAS NOTED THAT A BROKEN SYRINGE TIP, CONSISTENT WITH BEING FROM THE SUPPLIED 60CC SYRINGE, WAS FOUND INSIDE THE ONE-WAY VALVE (INP-7). THE BROKEN SYRINGE TIP WAS REMOVED FROM THE ONE-WAY VALVE; NO OTHER DAMAGE WAS NOTED (INP-8). 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-9, INP-10, INP-11). THE CENTER POST OF THE FOS WAS CENTERED. THE BLUE CLAMSHELL HO USING WAS EXAMINED, AND NO ABNORMALITIES WERE NOTED. THE CAL KEY WAS INTACT; NO DAMAGE OR ABNORMALITIES WERE NOTED. THE BLADDER THICKNESS WAS MEASURED AT SIX POINTS WITH MEASUREMENTS RANGING FROM 0.0063IN-0.0066IN 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 ACCORDING TO 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 TO 180 DEGREES; THE CAL KEY WAS RECOGNIZED AGAIN. THE FOS WAS RECOGNIZED AND ZEROED BY THE IABP (ANP-2). THE PUMP STATUS DISPLAYED "OK" INDICATING THE FIBER IS FULLY INTACT (ANP-3). 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 IABC WAS LEAK TESTED USING THE LT-L-015 IN ACCORDANCE WITH TESTING METHODS FROM MANUFACTURING PROCEDURE. NO LEAKS WERE DETECTED. FULL INFLATION WAS ACHIEVED. THE DEVICE PASSED THE LEAK TEST. THE IABC WAS CONNECTED TO AN IABP WITH THE RETURNED 40CC INFLATION DRIVELINE TUBING. THE IABC WAS INSERTED INTO THE "T" TUBE AND 75MMHG BACKPRESSURE WAS APPLIED. THE IABC WAS PUMPED FOR A MINIMUM OF 15 MINUTES. THERE WERE NO ALARMS TRIGGERED. THE BLADDER INFLATED AND DEFLATED COMPLETELY WITH EACH BEAT. 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. SOME BLOOD EXITED WITH THE GUIDEWIRE. THE GUIDEWIRE WAS FRONT LOADED THROUGH THE IABC LUER. NO RESISTANCE WAS NOTED; THE GUIDEWIRE WAS ABLE TO ADVANCE THROUGH THE CENTRAL LUMEN. NO BLOOD OR DEBRIS WAS NOTED. AN ATTEMPT TO ASPIRATE AND FLUSH THE CATHETER USING A 60CC LAB-INVENTORY SYRINGE WAS UNABLE TO BE SUCCESSFULLY COMPLETED BEFORE INSERTING THE GUIDEWIRE. ANOTHER ATTEMPT TO ASPIRATE AND FLUSH THE CATHETER WAS SUCCESSFULLY COMPLETED, AFTER CLEARING BLOOD FROM THE CENTRAL LUMEN DURING THE GUIDEWIRE TEST. 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 ROOT CAUSE OF THE COMPLAINT WAS UNDETERMINED. NO FURTHER ACTION REQUIRED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE BALLOON DID NOT FULLY UNWRAP. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE BALLOON DID NOT FULLY UNWRAP. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766889 ULTRAFLEX IAB: 7.5FR 40CC SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC IPN039788 18F23B0008 10801902145731

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown