BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 2033922 · Received February 11, 2011

    Report

    Report Number
    1219856-2011-00053
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 7, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    Z-0790/0793-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    UNKNOWN

    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 A MALE PT IN THE CATH LAB WITH THE DIAGNOSIS OF MI WAS HAVING AN INTRA-AORTIC BALLOON (IAB) INSERTED. THE MD FOLLOWED THE INSTRUCTIONS FOR USE AND INSERTED THE SUPER ARROW-FLEX (SAF) SHEATH IN THE LEFT FEMORAL ARTERY. WHEN INSERTING THE IAB THROUGH THE SAF SHEATH, THE CATHETER WOULD NOT ADVANCE DUE TO RESISTANCE. THE CATHETER AND SHEATH WERE REMOVED TOGETHER. A NEW KIT WAS OPENED OF THE SAME AND PLACED SUCCESSFULLY VIA THE SAME INSERTION SITE. THERE WAS NO EXCESSIVE BLEEDING, INJURIES OR COMPLICATIONS. A DELAY IN THERAPY OF 10 MINUTES IS LISTED TO REMOVE AND REPLACE THE IAB CATHETER. THE PT OUTCOME IS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. MF0053023

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK