BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDIGUARD IAB: 8FR 40CC

    MDR report key: 18436563 · Received January 3, 2024

    Report

    Report Number
    3010532612-2024-00009
    Event Type
    Malfunction
    Date Received
    January 3, 2024
    Date of Event
    December 6, 2023
    Report Date
    December 27, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    00801902002679
    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). OTHER REMARKS: N/A; CORRECTED DATA: N/A.

    Additional Manufacturer Narrative · 0

    (B)(4). THE REPORTED COMPLAINT THAT "THE CATHETER CANNOT BE INSERTED" WAS CONFIRMED UPON INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED A 40CC 8.0FR REDIGUARD INTRA-AORTIC BALLOON CATHETER (IABC) WITH AN ORIGINAL PACKAGING BOX THAT DOES NOT MATCH THE SERIAL NUMBER ON THE RETURNED IABC (INP-2, INP-3, 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 THE SUPPLIED 40CC DRIVELINE TUBING, TWO (2) SUPPLIED 60CC SYRINGES, THE LONG AND SHORT ARTERIAL PRESSURE TUBING, TWO (2) SUPER ARROW-FLEX (SAF) SHEATHS W/SIDEARM, AND DATA-SCOPE INFLATION TUBING, WHICH APPEARED SEALED AND UNUSED (INP-5, INP-10 THROUGH INP-13). UPON RETURN, THE PEEL AWAY SHEATH WAS NOTED CONNECTED TO THE HEMOSTASIS CUFF (INP-14). THE ONE-WAY VALVE WAS TETHERED AND CONNECTED TO THE SHORT DRIVELINE TUBING (INP-7). THE BLADDER WAS FULLY UNWRAPPED; THE BLADDER WAS NOTED BUNCHED UP NEAR THE IABC DISTAL TIP (INP-8, INP-9). THE IABC CENTRAL LUMEN WAS NOTED BROKEN AT APPROXIMATELY 23.4CM FROM THE IABC DISTAL TIP (INP-15). 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 0.0072IN-0.0078IN 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. 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 IN ACCORDANCE WITH TESTING METHODS FROM MANUFACTURING PROCEDURE. A LEAK WAS IMMEDIATELY DETECTED FROM THE IABC DISTAL TIP AND IABC LUER END (ANP-1, ANP-2). THE LEAK FROM THE IABC DISTAL TIP AND IABC LUER END ARE CONSISTENT WITH THE PREVIOUSLY CONFIRMED DAMAGED CENTRAL LUMEN (INP-15). THE IABC WAS LEAK TESTED AGAIN WITH THE IABC DISTAL TIP AND LUER END BLOCKED OFF; NO OTHER LEAKS WERE DETECTED. A LAB INVENTORY 0.025IN GUIDEWIRE WAS BACK LOADED THROUGH THE IABC DISTAL TIP. RESISTANCE WAS NOTED AT APPROXIMATELY 9.4CM FROM THE IABC DISTAL TIP. THE GUIDEWIRE MET RESISTANCE AND COULD NOT ADVANCE AT APPROXIMATELY 21.9CM FROM THE IABC DISTAL TIP. SOME BLOOD AND DEBRIS WERE NOTED ON THE GUIDEWIRE UPON REMOVAL. THE GUIDEWIRE WAS FRONT LOADED THROUGH THE IABC LUER. THE GUIDEWIRE MET RESISTANCE AND COULD NOT ADVANCE APPROXIMATELY 4.2CM FROM THE LUER. THE CENTRAL LUMEN WAS LIKELY BLOCKED BY DRIED BLOOD. 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 DAMAGED CENTRAL LUMEN. THE ROOT CAUSE WAS UNDETERMINED. NO FURTHER ACTION REQUIRED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, "CATHETER DISALLOWED INSERTION, FOUND FRONT END RUPTURE". AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, "CATHETER DISALLOWED INSERTION, FOUND FRONT END RUPTURE". AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1506723 REDIGUARD IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC 18F23E0018 00801902002679

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male