BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW ULTRAFLEX IAB: 7.5FR 30CC

    MDR report key: 18672749 · Received February 8, 2024

    Report

    Report Number
    3010532612-2024-00107
    Event Type
    Malfunction
    Date Received
    February 8, 2024
    Date of Event
    December 26, 2023
    Report Date
    January 26, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    00801902003751
    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 REPORTED COMPLAINT OF IAB CATHETER STUCK IN SHEATH WAS CONFIRMED UPON INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED A 30CC 7.5FR ULTRAFLEX INTRA-AORTIC BALLOON CATHETER (IABC) WITH THE ORIGINAL PACKAGING THAT MATCHES THE SERIAL NUMBER ON THE RETURNED SAMPLE (INP-2, INP-4) FOR INVESTIGATION. THE SAMPLE WAS RETURNED IN A CARDBOARD BOX AND WAS LOOSELY PACKED WITHIN THE ORIGINAL PACKAGING CARTON (INP-1, INP-5). RETURNED WITH THE SAMPLE WAS SUPPLIED KIT COMPONENTS INCLUDING 30CC INFLATION DRIVELINE TUBING AND A 0.025IN GUIDEWIRE; NO DAMAGE OR ABNORMALITIES WERE NOTED TO THE RETURNED COMPONENTS (INP-6). UPON RETURN, THE TEFLON SHEATH WAS NOTED ON THE IABC BLADDER (INP-6, INP-8). THE DISTAL END OF THE TEFLON SHEATH WAS NOTED AT APPROXIMATELY 3.5CM FROM THE IABC DISTAL TIP; LIQUID BLOOD WAS NOTED WITHIN THE SHEATH SIDEARM (INP-6, INP-8, AND INP-9). THE ONE-WAY VALVE WAS TETHERED TO THE SHORT DRIVELINE TUBING (INP-7). THER SUPPLIED DATA-SCOPE INFLATION DRIVELINE TUBING WAS NOTED CONNECTED TO THE SHORT DRIVELINE TUBING; NO DAMAGE OR ABNORMALITIES WERE NOTED (INP-7). THE EXPOSED PORTION OF THE BLADDER WAS NOTED SLIGHTLY UNWRAPPED (INP-9). A SLIGHT BEND TO THE IABC CENTRAL LUMEN WAS NOTED AT APPROXIMATELY 9.8CM FROM THE IABC DISTAL TIP (INP-6, INP-8). DRIED BLOOD WAS NOTED ON THE EXTERIOR SURFACES OF THE RETURNED IABC. NO BLOOD WAS NOTED WITHIN THE HELIUM PATHWAY. THE BLADDER THICKNESS WAS MEASURED AT SIX POINTS WITH MEASUREMENTS RANGING FROM 0.0062IN-0.0067IN 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 IABC CENTRAL LUMEN WAS SUCCESSFULLY ASPIRATED AND FLUSHED USING A 60CC LAB-INVENTORY SYRINGE. SOME BLOOD EXITED. THE ONE-WAY VALVE WAS CONNECTED TO THE SHORT DRIVELINE TUBING AND VACUUM WAS PULLED ON THE IABC. WHILE MAINTAINING THE VACUUM, THE SHEATH WAS REMOVED FROM THE BLADDER WITHOUT ANY DIFFICULTY. THE BLADDER APPEARED TYPICAL; NO DAMAGE OR ABNORMALITIES WERE NOTED TO THE BLADDER (ANP-1). 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. NO RESISTANCE WAS NOTED; THE GUIDEWIRE WAS ABLE TO ADVANCE THROUGH THE CENTRAL LUMEN. SOME BLOOD WAS NOTED ON 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. SOME BLOOD WAS NOTED ON THE GUIDEWIRE. 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 BENT CENTRAL LUMEN. THE ROOT CAUSE OF THE COMPLAINT WAS UNDETERMINED. A MOST PROBABLE POTENTIAL ROOT CAUSE IS CUSTOMER HANDLING. NO FURTHER ACTION REQUIRED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED " THE BALLOON WAS PLACED USING A SHEATH WITH A LATERAL ARM, WHICH WAS OBSTRUCTED DURING BALLOON PUSHING AND COULD NOT ADVANCE, AND AFTER TRYING OTHER METHODS, IT STILL COULD NOT PASS THROUGH THE SHEATH. THE BALLOON WAS WITHDRAWN, BUT THE BALLOON COULD NOT BE WITHDRAWN FROM THE SHEATH, AND THE SHEATH WAS REMOVED AT THE SAME TIME AS THE BALLOON. THE BALLOON WAS REPLACED WITH A NEW ONE, AND THE PLACEMENT WAS NORMAL." SECOND DEVICE PLACED WITHIN SAME INSERTION SITE. NO PATIENT INJURY OR CONSEQUENCE REPORTED. PATIENT'S CURRENT CONDITION REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED " THE BALLOON WAS PLACED USING A SHEATH WITH A LATERAL ARM, WHICH WAS OBSTRUCTED DURING BALLOON PUSHING AND COULD NOT ADVANCE, AND AFTER TRYING OTHER METHODS, IT STILL COULD NOT PASS THROUGH THE SHEATH. THE BALLOON WAS WITHDRAWN, BUT THE BALLOON COULD NOT BE WITHDRAWN FROM THE SHEATH, AND THE SHEATH WAS REMOVED AT THE SAME TIME AS THE BALLOON. THE BALLOON WAS REPLACED WITH A NEW ONE, AND THE PLACEMENT WAS NORMAL." SECOND DEVICE PLACED WITHIN SAME INSERTION SITE. NO PATIENT INJURY OR CONSEQUENCE REPORTED. PATIENT'S CURRENT CONDITION REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82208 ARROW ULTRAFLEX IAB: 7.5FR 30CC SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC 18F23K0061 00801902003751

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male