BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 1847144 · Received September 24, 2010

    Report

    Report Number
    1219856-2010-00673
    Event Type
    Injury
    Date Received
    September 24, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 22, 2010
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REFERENCE MDR #1219856-2010-00672 FOR THE FIRST EVENT INVOLVING THE SAME PATIENT. IT WAS REPORTED THAT IN THE CATH LAB, A FEMALE PATIENT WAS HAVING AN INTRA-AORTIC BALLOON (IAB) INSERTED WITH A SUPER ARROW-FLEX (SAF) SHEATH. THEY HAVE NOTICED SERIOUS DIFFICULTIES ON THE INSERTION OF THE IAB THROUGH THE SAF INTRODUCER. THESE DIFFICULTIES HAS CAUSED THEM TO REPLACE TWO SAF INTRODUCERS AND USE A NON SAF INTRODUCER VIA THE OTHER FEMORAL ARTERY. THERE WAS NO PATIENT DEATH, COMPLICATIONS OR INJURIES. THE DELAY IN THERAPY WAS 20 MINUTES WHILE ANOTHER CATHETER WAS SUCCESSFULLY PLACED VIA ANOTHER FEMORAL INSERTION SITE. THE PATIENT IS LISTED AS "FINE".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other