BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 30 CC FOS

    MDR report key: 1734848 · Received June 4, 2010

    Report

    Report Number
    1219856-2010-00370
    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. PER THE MD, "THE IAB IS DAMAGED AND CAN NOT BE USED." THE MD REMOVED THE IAB AND SHEATH AS ONE UNIT. THE MD USED ANOTHER IAB-05830-LWS WITH SUCCESS. THERE WAS NO REPORTED PT DEATH. THE PT WAS NOT INJURED 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 (B)(4)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. MF9100006

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK