BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB 8 FR - 40 CC FOS

    MDR report key: 2141153 · Received June 22, 2011

    Report

    Report Number
    1219856-2011-00213
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS EVENT OCCURRED WHILE IN (B)(6). THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED THROUGH THE SHEATH VIA THE LEFT FEMORALIS WITH SUCCESS. AFTER 24 HOURS OF THERAPY, THE HELIUM LINE WAS OBSERVED TO HAVE BLOOD IN IT. AS A RESULT, THE IAB WAS REMOVED AND NOT REPLACED SINCE THERAPY WAS FINISHED. THERE WAS NOT HARM TO THE PATIENT. THERE IS NO REPORT OF PATIENT DEATH, COMPLICATIONS OR INJURY. THE PATIENT OUTCOME IS OKAY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011 FROM THE (B)(6) STATED THAT THE IAB WAS IN USE FOR (B)(6) PRIOR TO THE EVENT. THE BLOOD WAS NOTICED IN THE HELIUM LINE AND THEY TRIED TO REMOVE THE CATHETER, BUT IT WAS NOT POSSIBLE. A CT WAS PERFORMED AND THEY REMOVED THE IAB BY SURGICAL INTERVENTION SINCE THE PATIENT HAS ARTERIAL PLAQUE AND THUS THE BALLOON GOT CAUGHT. THE PATIENT OUTCOME IS 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. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention