BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 7.5 FR - 40 CC

    MDR report key: 1011625 · Received March 10, 2008

    Report

    Report Number
    1219856-2008-00118
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 22, 2008
    Report Date
    March 10, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION. WHILE INSERTING THE IAB INTO THE SHEATH, IT UNRAVELED. THE MD REMOVED THE IAB FROM THE SHEATH AND REQUESTED ANOTHER IAB. THE THIRD IAB WAS INSERTED INTO THE SHEATH WITHOUT INCIDENT. REFERENCE MEDWATCH 1219856-2008-00117 FOR THE FIRST EVENT INVOLVING THE SAME PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 7.5 FR - 40 CC INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ULTRA 8 INTRA-AORTIC BALLOON