BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB: 8 FR-30 CC

    MDR report key: 1669050 · Received April 16, 2010

    Report

    Report Number
    1219856-2010-00243
    Event Type
    Injury
    Date Received
    April 16, 2010
    Date of Event
    March 25, 2010
    Report Date
    April 16, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT WHILE IN THE CATH LAB, THE IAB WAS INSERTED INTO THE SAF SHEATH. THE IAB BECAME STUCK IN THE SHEATH AND AS A RESULT THE IAB AND THE SAF SHEATH WERE REMOVED AS ONE UNIT. ANOTHER IAB WAS PREPPED AND INSERTED WITHOUT DIFFICULTY INTO THE OTHER LEG, AND MANUAL PRESSURE WAS USED TO STOP THE BLEEDING AT THE FIRST INSERTION SITE. THE EVENT INVOLVED A FEMALE PT, (B) (6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR-30 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention