BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDIGUARD IAB: 8FR 40CC

    MDR report key: 17151675 · Received June 19, 2023

    Report

    Report Number
    3010532612-2023-00332
    Event Type
    Malfunction
    Date Received
    June 19, 2023
    Date of Event
    April 18, 2023
    Report Date
    May 29, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    10801902145656
    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

    QN# (B)(4). OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Additional Manufacturer Narrative · 0

    (B)(4). THE REPORTED COMPLAINT FOR IAB "AIR LEAKAGE" WAS CONFIRMED BASED UPON THE SAMPLE RECEIVED. THE CUSTOMER RETURNED A 40CC 8.0FR REDIGUARD INTRA-AORTIC BALLOON CATHETER (IABC) WITH THE ORIGINAL PACKAGING BOX, THAT MATCHES THE SERIAL NUMBER ON THE RETURNED SAMPLE (INP-2, INP-3), FOR INVESTIGATION. THE SAMPLE WAS RETURNED IN A CARDBOARD BOX AND WAS LOOSELY PACKED WITHIN THE ORIGINAL PACKAGING BOX (INP-1, INP-5). RETURNED WITH THE SAMPLE WAS A 30CC INFLATION DRIVELINE TUBING, VARIOUS AP TUBING (TWO SHORT EXTENSION TUBING AND ONE 60" TUBING), RED END CAP AND 60CC LUER SLIP SYRINGE PLUNGER; ALL COMPONENTS WERE VISUALLY INSPECTED, AND NO ABNORMALITIES WERE NOTED (INP-6). ALSO RETURNED WITH THE SAMPLE WAS VARIOUS INSERTION KIT COMPONENTS, WHICH WERE VISUALLY INSPECTED, AND NO ABNORMALITIES WERE NOTED (INP-7). UPON RETURN, THE PEEL AWAY SHEATH WAS NOTED ON THE RETURNED IABC (INP-10). THE ONE-WAY VALVE WAS CONNECTED AND TETHERED TO THE SHORT DRIVELINE TUBING (INP-11). THE IABC BLADDER WAS FULLY UNWRAPPED (INP-12). DRIED BLOOD WAS NOTED ON THE EXTERIOR SURFACES OF THE RETURNED IABC; NO OBVIOUS BLOOD WAS NOTED WITHIN THE HELIUM PATHWAY. UPON RETURN, THE ORIGINAL PACKAGING TRAY WAS IMMEDIATELY NOTED WITH SLIGHT DAMAGE TO THE RIGHT SIDE OF THE "ARROW" PACKAGING STICKER WHICH RETAINS THE IABC BLADDER IN THE PACKAGING TRAY (INP-8, INP-9). THE EDGE OF THE ARROW STICKER WAS NOTED RIPPED (INP-9), WHICH WAS NOT TO BE REMOVED. THE DAMAGE TO THE PACKAGING STICKER WAS MINIMAL AND THE REMAINING PACKAGING STICKER/TRAY WAS NOTED UNDAMAGED. THERE IS NO CLEAR EVIDENCE THAT THE USER ATTEMPTED TO REMOVE THE IABC INCORRECTLY; THEREFORE, NO IN-SERVICE WOULD BE REQUESTED. THE IFU WITH THIS PRODUCT STATES: "1. CONNECT ONE-WAY VALVE TO MALE LUER ON SHORT DRIVELINE TUBING ATTACHED TO IAB. INSERT SUPPLIED SYRINGE INTO ONE-WAY VALVE. SLOWLY ASPIRATE A FULL SYRINGE OF AIR. PRECAUTION: THE ONE-WAY VALVE WILL MAINTAIN VACUUM ON THE BALLOON AND MUST REMAIN IN PLACE UNTIL IS FULLY INSERTED. REMOVE SYRINGE. 2. REMOVE CATHETER FROM TRAY, KEEPING IT IN LINE WITH BALLOON MEMBRANE. 3. GRASP CATHETER CLOSE TO TRAY AND PULL IT STRAIGHT OUT OF THE HOLDING SLEEVE. NOTE: KEEP CATHETER LEVEL WITH TRAY. DO NOT LIFT OR BEND DURING REMOVAL." THE BLADDER THICKNESS WAS MEASURED AT SIX POINTS WITH MEASUREMENTS RANGING FROM 0.0068IN-0.0076IN AND WAS WITHIN SPECIFICATION OF PROCESS DOCUMENT. AS PART OF FUNCTIONAL INSPECTION, 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 SUCCESSFULLY ASPIRATED AND FLUSHED USING A 60CC LAB-INVENTORY SYRINGE. SOME BLOOD WAS NOTED. THE IABC WAS LEAK TESTED USING THE LT-L-015 IN ACCORDANCE WITH TESTING METHODS FROM MANUFACTURING PROCEDURE. A LEAK WAS IMMEDIATELY DETECTED FROM THE BLADDER MEMBRANE (ANP-1). UNDER MICROSCOPIC INSPECTION, A PUNCTURE ON THE IABC BLADDER, CONSISTENT WITH CONTACT FROM A SHARP OBJECT, WAS NOTED AT APPROXIMATELY 10.4CM FROM THE IABC DISTAL TIP (ANP-2, ANP-3). NO OTHER LEAKS WERE DETECTED. A LAB INVENTORY 0.025IN GUIDEWIRE WAS BACK LOADED THROUGH THE IABC DISTAL TIP. RESISTANCE WAS NOTED AT APPROXIMATELY 20.9CM FROM THE IABC DISTAL TIP. 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 69.0CM FROM THE IABC LUER. 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. HOWEVER, THE SPECIFICATIONS WERE NOT MET DURING THE COMPLAINT INVESTIGATION DUE TO T HE BLADDER LEAK. THE ROOT CAUSE OF THE BLADDER LEAK WAS UNDETERMINED. THE MOST PROBABLE POTENTIAL CAUSE OF HOW THE CATHETER CAME INTO CONTACT WITH A SHARP OBJECT WAS CUSTOMER HANDLING. NO FURTHER ACTION REQUIRED AT THIS TIME. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "AFTER INSERTING AN IABP BALLOON CATHETER ON THE LEFT SIDE, AIR LEAKAGE WAS FOUND, AND THE CATHETER WAS IMMEDIATELY WITHDRAWN AND REPLACED WITH A NEW ONE". THE 2ND IAB 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 "AFTER INSERTING AN IABP BALLOON CATHETER ON THE LEFT SIDE, AIR LEAKAGE WAS FOUND, AND THE CATHETER WAS IMMEDIATELY WITHDRAWN AND REPLACED WITH A NEW ONE". THE 2ND IAB 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
    813935 REDIGUARD IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC IPN039780 18F22E0039 10801902145656

    Patients

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