BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 30 CC FOS

    MDR report key: 1944007 · Received December 3, 2010

    Report

    Report Number
    1219856-2010-00876
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 30, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE, PT, WAS IN THE CATH LAB HAVING AN INTRA-AORTIC BALLOON (IAB) INSERTED VIA THE FEMORAL ARTERY. THE IAB WAS BEING INSERTED SHEATHLESS. DURING THE INSERTION, THE IAB COULD NOT BE ADVANCED INTO THE ARTERY AND BECAME STUCK. IT WAS NOTICED THAT THE IAB STARTED TO UNWRAP. THE IAB WAS REMOVED AND REPLACED. THERE WAS A DELAY IN THERAPY WITH UNSUCCESSFUL ATTEMPTS. REFERENCE MDR #1219856-2010-00877 FOR THE SECOND EVENT INVOLVING THE SAME PT.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR