BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB: 8 FR - 30 CC FOS

    MDR report key: 1611891 · Received February 12, 2010

    Report

    Report Number
    1219856-2010-00080
    Event Type
    Injury
    Date Received
    February 12, 2010
    Date of Event
    January 21, 2010
    Report Date
    February 12, 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
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REFERENCE MDR #1219856-2010-00078 FOR THE FIRST EVENT AND MDR #1219856-2010-00079 FOR THE SECOND EVENT INVOLVING THE SAME PATIENT. IT WAS REPORTED THAT AFTER THE MD ABORTED THE SECOND ATTEMPT, THE STAFF EXAMINED THE SECOND IAB AND WERE SUCCESSFUL IN ADVANCING IT THROUGH THE SECOND SUPER ARROW-FLEX (SAF) SHEATH WHEN IT WAS OUTSIDE OF THE BODY. THE SECOND INTRA-AORTIC BALLOON (IAB) WAS STILL INTACT. THEY TOLD THE MD THAT IT WAS A SHEATH ISSUE, NOT AN IAB ISSUE, SO THE MD SCRUBBED BACK IN AND INSERTED THE SECOND IAB THROUGH THE SECOND SAF SHEATH. THE FIRST IAB WAS DISCARDED AND ONLY THE FIRST SAF SHEATH WAS RETURNED. THE SECOND IAB AND SECOND SAF SHEATH WERE NOT SAVED AFTER WEANING. THE STAFF DID NOT COMMENT ON EXCESSIVE BLEEDING. ACCESS WAS INTERRUPTED, AS THE STAFF TOLD ME THAT THE MD HAD TO SCRUB BACK IN.

    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) DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other