BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR 40 CC FOS

    MDR report key: 1734874 · Received June 4, 2010

    Report

    Report Number
    1219856-2010-00367
    Event Type
    Malfunction
    Date Received
    June 4, 2010
    Date of Event
    May 17, 2010
    Report Date
    June 2, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CATH LAB, THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED AND THE MD INSERTED THE SHEATH INTO THE PATIENT'S RIGHT GROIN. THE MD FOUND THAT THE IAB COULD NOT BE ADVANCED THROUGH THE SHEATH. AS A RESULT, THE IAB WAS REMOVED AND THE MD INSERTED AN IAB-S840C SUCCESSFULLY. THERE WAS NO REPORTED PATIENT DEATH, THE PATIENT WAS NOT INJURED AND DID NOT REQUIRE MEDICAL OR SURGICAL INTERVENTION. THE DELAY IN THERAPY WAS STATED AS: LONG ENOUGH TO REMOVE THE IAB-05840-LWS AND REPLACE IT WITH THE IAB-S840C. THERE WERE NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS TRANSFERRED TO THE CARDIAC CARE UNIT.

    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. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR