BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8FR - 40CC

    MDR report key: 1963646 · Received December 21, 2010

    Report

    Report Number
    1219856-2010-00911
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 22, 2010
    Report Date
    December 21, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DISTRIBUTOR THAT THE HOSPITAL REPORTED AN INCIDENT INVOLVING A PT IN THE CARDIOVASCULAR DEPARTMENT. THE INTRA-AORTIC BALLOON (IAB) WAS BEING ADMINISTERED FOR ISCHEMIA AND CARDIAC FAILURE. THE MD INSERTED THE IAB VIA THE SUPER ARROW-FLEX (SAF) SHEATH IN THE RIGHT FEMORAL ARTERY. THE IAB STOPPED AND COULD NOT BE ADVANCED FORWARD OR BACK. THE MD REMOVED THE IAB AND SHEATH TOGETHER, WITH A FEMORAL HEMATOMA DEVELOPING. NO SURGICAL INTERVENTION WAS REQUIRED. THE PT WAS IN CRITICAL CONDITION. REFERENCE MDR #1219856-2010-00912 FOR SECOND EVENT INVOLVING THE SAME PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8FR - 40CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR NOREPINEPHRINE