BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 30 CC FOS

    MDR report key: 1734869 · Received June 4, 2010

    Report

    Report Number
    1219856-2010-00369
    Event Type
    Malfunction
    Date Received
    June 4, 2010
    Date of Event
    May 23, 2010
    Report Date
    June 3, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOS
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED AND THE SHEATH WAS INSERTED INTO THE PT. THE MD FOUND IT WAS IMPOSSIBLE TO INSERT THE IAB THROUGH THE SHEATH. AS A RESULT, THE IAB WAS NOT INSERTED AND THE IAB AND THE SHEATH WERE REMOVED AS ONE UNIT. THE MD USED ANOTHER IAB-05830-LWS WITH SUCCESS. THERE WAS NO REPORTED PT DEATH. THE PT WAS NOT REQUIRED, AND THERE WERE NO REPORTED PT COMPLICATIONS. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PT'S OUTCOME IS LISTED AS "FINE". ADDITIONAL INFO RECEIVED ON 06/03/2010 FROM (B)(6) STATED THAT THE ANATOMICAL INSERTION SITE WAS THE RIGHT FEMORAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 30 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) FOS ARROW INTL., INC. MF9109757

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK