BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 1881127 · Received October 1, 2010

    Report

    Report Number
    1219856-2010-00694
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 11, 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). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CATH LAB, THE CARDIOLOGIST TRIED TO PLACE THE INTRA-AORTIC BALLOON (IAB) AND IT BECAME STUCK IN THE SHEATH. THE INSERTION SITE WAS THE GROIN. THE MD CAREFULLY PULLED THE CATHETER OUT OF THE SUPER ARROW-FLEX (SAF) SHEATH AND THE TEFLON SHEATH WAS CONTAMINATED SO THEY USED ANOTHER NON ARROW 8 FRENCH SHEATH. THE SAME IAB WAS INSERTED SUCCESSFULLY THROUGH THE OTHER SHEATH. THERE WAS NO REPORTED PT DEATH OR INJURY. THERE WAS NO DELAY OR INTERRUPTION IN THERAPY. THE PT OUTCOME 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