BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBEROPTIX ULTRA 8 IAB: 8FR 40CC

    MDR report key: 17100442 · Received June 9, 2023

    Report

    Report Number
    3010532612-2023-00321
    Event Type
    Malfunction
    Date Received
    June 9, 2023
    Date of Event
    May 18, 2023
    Report Date
    May 22, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    00801902136718
    PMA / PMN Number
    K021462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) THE REPORTED COMPLAINT FOR "BALLOON FAILED TO FULLY UNWRAP" WAS CONFIRMED THROUGH EXAMINATION OF THE RETURNED SAMPLE. THE CUSTOMER R RETURNED FOR INVESTIGATION A 40CC 8.0FR FOS INTRA-AORTIC BALLOON CATHETER (IABC) WITHOUT THE ORIGINAL PACKAGING. THE SAMPLE WAS RETURNED IN THE SUPPLIED RETURN KIT AND WAS IN A SEALED BIO-HAZARD BAG (INP-1, INP-2). UPON RETURN, A PORTION OF THE BLADDER WAS NOTED COVERED BY THE TEFLON SHEATH NEAR THE PROXIMAL END OF THE BLADDER; THE DISTAL END OF THE TEFLON SHEATH WAS NOTED AT APPROXIMATELY 25.4CM FROM THE IABC DISTAL TIP AND THE TEFLON SHEATH HUB WAS NOTED CONNECTED TO THE HEMOSTASIS CUFF (INP-4, INP-6, AND INP-8). THE ONE-WAY VALVE WAS CONNECTED AND TETHERED TO THE SHORT DRIVELINE TUBING (INP-5). THE SUPPLIED SHORT ARTERIAL PRESSURE TUBING WAS NOTED CONNECTED TO THE IABC LUER; CLEAR FLUID WAS NOTED WITHIN THE AP TUBING (INP-5). THE BLADDER WAS NOTED WRAPPED (OR CONSIDERED TWISTED) NEAR THE DISTAL TIP AND NEAR THE PROXIMAL END OF THE BLADDER; THE REST OF THE BLADDER NOTED FULLY UNWRAPPED (INP-6, INP-7, AND INP-8). A KINK TO THE IABC/SHEATH EXTRUSION WAS NOTED AT APPROXIMATELY 40.2CM FROM THE IABC DISTAL TIP (INP-9). SPOTS OF DRIED BLOOD WERE NOTED ON THE EXTERIOR SURFACES OF THE RETURNED IABC. NO BLOOD WAS NOTED WITHIN THE HELIUM PATHWAY. 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-10, INP-11, AND INP-12). THE CENTER POST OF THE FOS WAS CENTERED. THE BLUE CLAMSHELL HOUSING WAS EXAMINED, AND NO ABNORMALITIES WERE NOTED. THE CAL KEY WAS INTACT. THE BLADDER THICKNESS WAS MEASURED AT SIX POINTS WITH MEASUREMENTS RANGING FROM (B)(4) 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 CAL KEY AND FOS WERE CONNECTED TO THE IABP. THE CAL KEY WAS RECOGNIZED. THE FOS WAS CONNECTED AND THE IABP ZEROED THE IABC (ANP-1). THE PUMP STATUS DISPLAYED "OK" INDICATING THE FIBER IS FULLY INTACT (ANP-2). THE IABC CENTRAL LUMEN WAS ASPIRATED AND FLUSHED USING A 60CC LAB-INVENTORY SYRINGE. NO ABNORMALITIES OR DEBRIS WERE NOTED. UPON RECEIPT, THE TEFLON SHEATH WAS NOTED ON A SECTION OF THE BLADDER MEMBRA NE; HOWEVER, THERE IS NO EVIDENCE THAT THE USER ATTEMPTED TO REMOVE THE IABC AND BLADDER THROUGH THE SHEATH. THE ONE-WAY VALVE WAS CONNECTED TO THE SHORT DRIVELINE TUBING AND VACUUM WAS PULLED ON THE IABC. WHILE MAINTAINING THE VACUUM, THE TEFLON SHEATH WAS CAREFULLY MOVED FROM THE BLADDER AND TOWARDS THE BIFURCATE WITH MINIMAL FORCE DUE TO THE KINKED IABC. UPON REMOVAL OF THE SHEATH FROM THE BLADDER, THE BLADDER WAS NOTED WRAPPED (OR CONSIDERED TWISTED) NEAR THE PROXIMAL END OF THE BLADDER; NO OTHER DAMAGE OR ABNORMALITIES WERE NOTED TO THE BLADDER (ANP-3, ANP-4). THE IABC WAS LEAK TESTED USING THE LT-L-015 IN ACCORDANCE WITH TESTING METHODS FROM MANUFACTURING PROCEDURE. DURING THE LEAK TEST, THE BLADDER DID NOT FULLY INFLATE. THE BODY OF THE BLADDER HAD INFLATED BUT THE DISTAL AND PROXIMAL PORTION OF THE BLADDER WOULD NOT FULLY UNWRAP AND WAS CONSISTENT WITH BEING TWISTED (ANP-5, ANP-6). NO LEAKS WERE DETECTED. A LAB INVENTORY 0.025IN GUIDEWIRE WAS BACK LOADED THROUGH THE IABC DISTAL TIP. THE GUIDEWIRE COULD NOT ADVANCE AT APPROXIMATELY 40.3CM FROM THE IABC DISTAL TIP, WHICH IS THE LOCATION OF THE PREVIOUSLY NOTED KINK. NO BLOOD OR DEBRIS WAS NOTED. THE GUIDEWIRE WAS FRONT LOADED THROUGH THE IABC LUER. THE GUIDEWIRE COULD NOT ADVANCE AT APPROXIMATELY 41.7CM FROM THE IABC LUER, WHICH IS THE LOCATION OF THE PREVIOUSLY NOTED KINK. NO BLOOD OR DEBRIS WAS NOTED. THE KINK NOTED TO THE IABC MOST LIKELY OCCURRED AFTER THE REMOVAL OF THE IABC FROM THE PATIENT OR DURING THE RETURNED SHIPPING/HANDLING. 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. FURTHER INVESTIGATION HAS BEEN INITIATED UNDER TELEFLEX'S QUALITY SYSTEM BY THE MANUFACTURING SITE TO FURTHER INVESTIGATE THE ISSUE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE. OTHER REMARKS: N/A CORRECTED DATA: N/A

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE REPORT STATES THAT WHILE IN USE ON A PATIENT, THE "BALLOON FAILED TO FULLY UNWRAP". AS A RESULT, THE IAB WAS REMOVED. A 2ND IAB WAS NOT INSERTED AS THE "PATIENT WAS IMPROVING". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    THE REPORT STATES THAT WHILE IN USE ON A PATIENT, THE "BALLOON FAILED TO FULLY UNWRAP". AS A RESULT, THE IAB WAS REMOVED. A 2ND IAB WAS NOT INSERTED AS THE "PATIENT WAS IMPROVING". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2228533 FIBEROPTIX ULTRA 8 IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC IPN038102 18F22H0009 00801902136718

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown