BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 30 CC FOS

    MDR report key: 1881107 · Received October 1, 2010

    Report

    Report Number
    1219856-2010-00686
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 3, 2010
    Report Date
    October 1, 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
    PA, 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 WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED AND THE SHEATH WAS INSERTED INTO THE PTS' FEMORAL ARTERY. THE IAB WAS INSERTED THROUGH THE SHEATH AND INTO THE PT. THE INTRA-AORTIC BALLOON PUMP (IABP) WAS INITIATED AND IT WAS FOUND THAT THE IAB MEMBRANE DID NOT INFLATE. THE IAB WAS REMOVED AND FOUND TO HAVE A KINK AT THE "BASE OF THE IAB." ANOTHER IAB WAS PREPPED AND INSERTED WITHOUT INCIDENT. THERE WAS NO REPORTED PT DEATH OR INJURY. THE DELAY IN TREATMENT WAS 10 MINUTES. THE OUTCOME OF THE PT IS "WENT TO UNIT." ADDITIONAL INFO RECEIVED FROM THE SALES REP ON 9/21/2010 STATED THAT "IT WAS THE SAME SHEATH AND SITE. PREPPED PER INSTRUCTION."

    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 INTL., INC. MF8124409

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK