BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 2193417 · Received July 13, 2011

    Report

    Report Number
    1219856-2011-00242
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 12, 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
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REFERENCE MDR # 1219856-2011-00240 FOR THE FIRST EVENT AND MDR #1219856-2011-00241 FOR THE SECOND EVENT INVOLVING THE SAME PT. IT WAS REPORTED THAT WHILE IN THE CATH LAB, THE MD INSERTED THE SHEATH INTO THE PT'S LEFT FEMORAL ARTERY. THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED AND UPON THE INITIAL INTRA-AORTIC BALLOON PUMP (IABP) START UP, IT WAS NOTED THAT THERE WAS NO AP (ARTERIAL PRESSURE) ON THE CONSOLE. THE RN IN THE ROOM NOTED THAT THE CENTRAL LUMEN WAS BLOCKED; THE MD THEN USED A SYRINGE TO FLUSH THE CENTRAL LUMEN WITH HEPARIN SALINE. BLOOD CLOTS WERE NOTED FROM THE CENTRAL LUMEN. THE MD DECIDED TO REMOVE THE IAB FROM THE PT DUE TO THE BLOCKED CENTRAL LUMEN AND THEY COULD NOT GET AN AP SIGNAL. ANOTHER IAB WAS NOT INSERTED. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. IABP THERAPY WAS DELAYED FOR OVER 8 MINUTES. THERE WERE NO REPORTED PT COMPLICATIONS AND THE PT OUTCOME IS NOT AVAILABLE. THE PT OUTCOME IS THE PT WAS TAKEN TO CORONARY BYPASS GRAFT SURGERY.

    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 KF1049926

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INTRA-AORTIC BALLOON PUMP