BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBEROPTIX ULTRA 8 IAB: 8FR 30CC

    MDR report key: 15526208 · Received October 2, 2022

    Report

    Report Number
    3010532612-2022-00397
    Event Type
    Malfunction
    Date Received
    October 2, 2022
    Date of Event
    September 2, 2022
    Report Date
    September 7, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    10801902161892
    PMA / PMN Number
    K021462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 0

    (B)(4). THE ORIGINAL EVENT REPORT WAS DOCUMENTED AS A MEDWATCH REPORT #2700040000-2022-8058 NO SERIAL NUMBER WAS REPORTED. THE SERIAL NUMBER ON THE RETURNED SAMPLE IS KM10700. THE LOT NUMBER 18F21K0087 RECORDED ON THE COMPLAINT REPORT MATCHES THE LOT NUMBER FOR THE RETURNED SAMPLE AND ON THE RETURNED PACKAGING BOX. RETURNED FOR INVESTIGATION WAS A 30CC 8.0FR FOS INTRA-AORTIC BALLOON CATHETER (IABC) WITH THE ORIGINAL PACKAGING BOX THAT MATCHES THE SERIAL NUMBER ON THE RETURNED SAMPLE. THE SAMPLE WAS RETURNED IN A CARDBOARD BOX AND WAS LOOSELY PACKED WITHIN THE ORIGINAL PACKAGING BOX/ZIPLOC BAG. RETURNED WITH THE SAMPLE WAS SUPPLIED 30CC INFLATION DRIVELINE TUBING; DRIED BLOOD WAS NOTED ON THE EXTERIOR SURFACES OF THE RETURNED DRIVELINE TUBING. NO DAMAGE OR ABNORMALITIES WERE NOTED TO THE RETURNED DRIVELINE TUBING. A 40CC INFLATION DRIVELINE TUBING CONNECTOR WAS ALSO RETURNED WITH THE SAMPLE. THE 40CC CONNECTOR RETURNED DISCONNECTED FROM THE INFLATION DRIVELINE TUBING; THE REMAINING LENGTH INCLUDING INFLATION DRIVELINE TUBING W/ WHITE FEMALE CONNECTOR WAS NOT RETURNED. THE RETURNED 40CC INFLATION DRIVELINE TUBING CONNECTOR IS NOTED TO BE FROM A 40CC INTRA-AORTIC BALLOON CATHETER (IABC) KIT. UPON RETURN, THE DISTAL END OF THE TEFLON SHEATH WAS NOTED AT APPROXIMATELY 39.4CM FROM THE IABC DISTAL TIP; THE TEFLON SHEATH HUB WAS NOTED CONNECTED TO THE HEMOSTASIS CUFF AND LIQUID BLOOD WAS NOTED WITHIN THE SHEATH SIDEARM. THE ONE-WAY VALVE WAS TETHERED TO THE SHORT DRIVELINE TUBING. THE BLADDER WAS FULLY UNWRAPPED. DRIED BLOOD WAS NOTED ON THE EXTERIOR SURFACES OF THE RETURNED SAMPLE. NO BLOOD WAS NOTED WITHIN THE HELIUM PATHWAY. NO VISUAL DAMAGE OR ABNORMALITIES WERE NOTED TO THE RETURNED IABC. 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. 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 0.0060IN-0.0062IN AND WAS WITHIN SPECIFICATION OF PROCESS DOCUMENT 13-0224 AND 13-0218. 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 Q-96. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR THE LOT NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE RISK IS ACCEPTABLE. THE RETURNED DEVICE PASSED VISUAL AND FUNCTIONAL TESTING. THE REPORTED COMPLAINT OF IAB WOULD NOT INFLATE COMPLETELY IS NOT CONFIRMED. THE RETURNED INTRA-AORTIC BALLOON CATHETER (IABC) BLADDER WAS FULLY INTACT WITH NO ABNORMALITIES NOTED. DURING FUNCTIONAL TESTING, THE IABC BLADDER INFLATED AND DEFLATED COMPLETELY WITH NO ALARMS NOTED. THE RETURNED DEVICE PASSED VISUAL AND FUNCTIONAL TEST SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD, THE PRODUCT MET SPECIFICATION UPON RELEASE. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. NO FURTHER ACTION REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BALLOON WAS DEFECTIVE; IT WOULD NOT PUMP/WORK. IT WAS USED AS INDICATED AND THE REPORTED ISSUE OCCURRED RIGHT AT THE FIRST INFLATION OF THE CATHETER. THERE WERE NO ISSUES AT THE INSERTION SITE. THE CATHETER WAS REPLACED WITH A NEW ONE THAT WORKED AS INTENDED. NO PUMP STRIPS WERE GENERATED FOR REVIEW. THERE WAS NO MEDICAL INTERVENTION OR NEGATIVE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2315995 FIBEROPTIX ULTRA 8 IAB: 8FR 30CC SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC IPN915317 18F21K0087 10801902161892

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown N/A.| NONE REPORTED.