BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 1230381 · Received November 7, 2008

    Report

    Report Number
    1219856-2008-00511
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    July 8, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED, IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2008, THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED INTO A (B)(6) MALE PT. "WHILE TRYING TO ZERO THE FIBEROPTIX SENSOR (FOS), A READING APPEARED ON THE CONSOLE SCREEN. FOS HAS BEEN ZEROED PREVIOUSLY." (THE CATHETER HAD BEEN REMOVED FROM THE SEALED PACKAGE AND IT WAS THE ONLY ATTEMPT TO ZERO.) THE CATHETER DID ZERO AND IT CONTINUED TO BE INSERTED OVER THE GUIDEWIRE. THE SURGEON COMPLAINED THE CATHETER WAS DIFFICULT TO PASS. THE SCRUB TEAM RECOMMENDED "WETTING" THE CATHETER. THE SURGEON DISCARDED THE CATHETER AND GUIDEWIRE AND REQUESTED A STANDARD IAB CATHETER WHICH WAS INSERTED WITH NO FURTHER PROBLEMS. THE INTRA-AORTIC BALLOON PUMP HAS BEEN USED SINCE, WITH ANOTHER FIBEROPTIC CATHETER, WITH NO ZEROING MESSAGES OR INSERTION PROBLEMS. THE CATHETER HAS BEEN WASHED, ALTHOUGH SOME BLOOD STAINS REMAIN IN THE LUMEN OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. MF8050720

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR INTRA-AORTIC BALLOON: (BRAND UNK)