BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 1881126 · Received October 1, 2010

    Report

    Report Number
    1219856-2010-00695
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED AND THE MD INSERTED THE SUPER ARROW-FLEX (SAF) SHEATH INTO THE PTS' GROIN. THE IAB BECAME STUCK IN THE SAF SHEATH AND AS A RESULT, THE IAB AND SAF SHEATH WERE REMOVED. THE MD INSERTED THE TEFLON SHEATH AND THE SECOND IAB WAS INSERTED WITHOUT DIFFICULTY. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE INTERVENTION IS LISTED AS "REMOVED IAB AND SHEATH". THERE WAS NO DELAY IN THERAPY. 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. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK