BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 30 CC FOS

    MDR report key: 1650480 · Received April 1, 2010

    Report

    Report Number
    1219856-2010-00214
    Event Type
    Malfunction
    Date Received
    April 1, 2010
    Date of Event
    March 14, 2010
    Report Date
    April 1, 2010
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 THAT THE INTRA-AORTIC BALLOON (IAB) WAS TO BE INSERTED EMERGENTLY IN THE CATH LAB. AFTER CREATING A VACUUM, THE IAB WAS REMOVED FROM THE TRAY. THE MD INSERTED THE SHEATH AND AS THE IAB WAS BEING ADVANCED THROUGH THE SHEATH, THE MEMBRANE BEGAN TO UNWRAP AT THE PROXIMAL SITE OF THE MEMBRANE. AS A RESULT, THE IAB COULD NOT BE INSERTED. THE MD REQUESTED AN IAB-05830-LWS AND THIS IAB WAS PREPPED AND INSERTED WITHOUT PROBLEMS. THERE WERE NO REPORTED PATIENT COMPLICATIONS. ADD'L INFO RECEIVED ON 03/19/2010 FROM THE SALES REP STATED THE IAB WAS PREPPED PER INSTRUCTION AND THE MD DID REMOVE THE IAB AND SHEATH AS ONE UNIT.

    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 INTERNATIONAL, INC. MF9099230

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK