BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW REDIGUARD IAB: 7FR 30CC

    MDR report key: 20372247 · Received October 4, 2024

    Report

    Report Number
    3010532612-2024-00814
    Event Type
    Malfunction
    Date Received
    October 4, 2024
    Date of Event
    August 20, 2024
    Report Date
    September 5, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    00801902002686
    PMA / PMN Number
    K981660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    QN# (B)(4). RETURNED FOR INVESTIGATION WAS A 30CC 7.0FR REDIGUARD INTRA-AORTIC BALLOON CATHETER (IABC) WITH THE ORIGINAL PACKAGING BOX THAT MATCHES THE SERIAL NUMBER FOR THE RETURNED SAMPLE. THE SAMPLE WAS RETURNED IN A CARDBOARD BOX AND WAS LOOSELY PACKED WITHIN THE ORIGINAL PACKAGING CARTON. UPON RE-TURN, THE SUPER ARROW-FLEX (SAF) SHEATH WAS NOTED CONNECTED TO THE HEMOSTASIS CUFF; DRIED BLOOD WAS NOTED IN THE SHEATH SIDEARM. THE LONG ARTERIAL PRESSURE TUBING WAS NOTED CONNECTED TO THE IABC LUER. THE ONE-WAY VALVE WAS TETHERED TO THE SHORT DRIVELINE TUBING. THE BLADDER WAS FULLY UNWRAPPED. A KINK TO THE IABC OUTER LUMEN WAS NOTED AT APPROXIMATELY 10.7CM FROM THE IABC DISTAL TIP. DRIED BLOOD WAS NOTED ON THE EXTERIOR SURFACES OF THE RETURNED SAMPLE. NO OBVIOUS BLOOD WAS NOTED WITHIN THE HELIUM PATHWAY. THE BLADDER THICKNESS WAS MEASURED AT SIX POINTS WITH MEASUREMENTS RANGING FROM 0.0065IN-0.0069IN 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 IN ACCORDANCE WITH QUALITY SYSTEM DOCUMENT. THE CATHETER'S 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 NOTED AND LOCATED AROUND THE BIFURCATE BUSHING. UPON MICROSCOPIC INSPECTION, AN EXTERNAL LEAK OCCURRED AT THE PROXIMAL END OF THE BUSHING AND THE APPEARANCE IS CONSISTENT WITH SHOWING A VOID. NO OTHER LEAKS WERE DETECTED. A LAB INVENTORY 0.025IN GUIDEWIRE WAS BACK LOADED THROUGH THE IABC DISTAL TIP. RESISTANCE WAS NOTED AT APPROXIMATELY 10.5CM FROM THE IABC DISTAL TIP, WHICH IS THE LOCATION OF THE PREVIOUSLY NOTED KINK. 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 IAB LEAK SUSPECTED IS CONFIRMED. AN EXTERNAL LEAK WAS CONFIRMED FROM THE IABC BIFURCATE BUSHING. THE RETURNED IABC BLADDER MEMBRANE WAS FULLY INTACT, WITH NO LEAKS 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 LEAK AT THE BIFURCATE BUSHING. THE ROOT CAUSE OF THE LEAK AT THE BIFURCATE BUSHING IS MANUFACTURING RELATED. CORRECTIONS HAVE BEEN ESTABLISHED FOR THIS ISSUE AS A RESULT OF A PREVIOUS NON-CONFORMANCE, AND THIS DEVICE WAS MANUFACTURED PRIOR TO THE RELEASE OF THOSE CORRECTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED "COUNTERPULSATION WAS INITIATED AFTER CATHETERIZATION. THERE HAS BEEN NO INDICATION OF INVASIVE BLOOD PRESSURE, AND USING A SYRINGE TO DRAW BACK BLOOD IN THE CENTRAL LUMEN FAILS TO DO SO, AND OBSERVATION ON THE DSA REVEALS THAT THE CATHETER IS FRACTURED, AND THE CATHETER IS IMMEDIATELY WITHDRAWN AND REPLACED WITH A NEW CATHETER". ADDITIONAL INFORMATION STATES THAT THE SECOND CATHETER WAS INSERTED INTO THE SAME INSERION SITE. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED "COUNTERPULSATION WAS INITIATED AFTER CATHETERIZATION. THERE HAS BEEN NO INDICATION OF INVASIVE BLOOD PRESSURE, AND USING A SYRINGE TO DRAW BACK BLOOD IN THE CENTRAL LUMEN FAILS TO DO SO, AND OBSERVATION ON THE DSA REVEALS THAT THE CATHETER IS FRACTURED, AND THE CATHETER IS IMMEDIATELY WITHDRAWN AND REPLACED WITH A NEW CATHETER". ADDITIONAL INFORMATION STATES THAT THE SECOND CATHETER WAS INSERTED INTO THE SAME INSERTION SITE. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726351 ARROW REDIGUARD IAB: 7FR 30CC SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC 18F24E0117 00801902002686

    Patients

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