BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 2193420 · Received July 13, 2011

    Report

    Report Number
    1219856-2011-00239
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT REQUIRED AN ANGIOPLASTY WITH CIRCULATORY ASSIST FOR AN ANTERIOR INFARCT. THE INTRA-AORTIC BALLOON (IAB) WAS SUCCESSFULLY INSERTED VIA THE PT'S FEMORAL ARTERY VIA A SHEATH. PER RADIOGRAPHIC THE IAB WAS ONLY 80% INFLATED, NEVERTHELESS THE IAB WAS USED FOR THIS PT. THERE WAS NO REPORTED PT DEATH OR INJURY. THERE WAS NO DELAY OR INTERRUPTION OF THERAPY. NO PT COMPLICATIONS WERE REPORTED AND THE PT OUTCOME IS LISTED AS 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 INTERNATIONAL INC KR1019059

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK