BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB: 8 FR -40 CC FOS

    MDR report key: 1895523 · Received November 5, 2010

    Report

    Report Number
    1219856-2010-00794
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 1, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A PHONE CALL FROM THE RN IN THE OPERATING ROOM TO THE COMPLAINT MGMT. DEPT, THAT WHILE IN THE OPERATING ROOM THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED AND THE MD INSERTED THE SUPER ARROW-FLEX (SAF) SHEATH IN THE PT'S FEMORAL ARTERY. THE MD FOUND THAT THE IAB BECAME STUCK IN THE SAF SHEATH AND REMOVED THE IAB AND SAF SHEATH AS ONE UNIT. A HEMATOMA WAS NOTICED AT THE INSERTION SITE AND PER THE RN "PRESSURE WAS APPLIED". THE MD PREPPED ANOTHER IAB AND INSERTED A NEW SHEATH INTO THE CONTRALATERAL SIDE OF THE PT. THE MD THEN INSERTED THE SECOND IAB (UNK PROD NUMBER) WITHOUT DIFFICULTIES. THERE WAS NO REPORTED PT DEATH. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THE DELAY IN THERAPY WAS DESCRIBED AS THE TIME FRAME IT TOOK TO PREP AND INSERT THE SECOND IAB SUCCESSFULLY. THE PT COMPLICATION IS THE HEMATOMA LOCATED AT THE FIRST INSERTION SITE. THE OUTCOME OF THE PT IS FINE.

    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. RF0098039

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other