BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 1230366 · Received November 7, 2008

    Report

    Report Number
    1219856-2008-00519
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 29, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WILL NOT BE RETURNED FOR EVALUATION. FOLLOW-UP REPORT WILL BE FILED, IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION. WHEN THE MD INSERTED THE SHEATH INTO THE PATIENT THE SHEATH KINKED. THE MD REQUESTED ANOTHER SHEATH AND AS A RESULT, THE CLINICIAN OPENED ANOTHER KIT AND TOOK THE INSERTION KIT OUT OF THAT KIT TO USE. THE IAB WAS ABLE TO BE INSERTED WITHOUT INCIDENT.

    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