BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 2193419 · Received July 13, 2011

    Report

    Report Number
    1219856-2011-00241
    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
    OTHER

    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 INVOLVING THE SAME PT. IT WAS REPORTED THAT WHILE IN THE CATH LAB THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED THROUGH A SHEATH INTO THE PT'S LEFT FEMORAL ARTERY. AFTER THE IAB WAS INSERTED AND PRIOR TO INTRA-AORTIC BALLOON PUMP (IABP) THERAPY, THE MD FLUSHED THE CENTRAL LUMEN WITH HEPARIN SALINE AND NOTED THAT THERE WAS NO BACK FLOW OF BLOOD IN THE A-LINE. THE MD USED A SYRINGE TO PULL BACK ON THE A-LINE AND ACCORDING TO THE MD THE "CENTRAL LUMEN SEEMED BLOCKED." THE MD THEN NOTICED THAT THERE WAS BLOOD IN THE GAS LINE. AS A RESULT, THE IAB WAS REMOVED AND A NEW IAB WAS 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. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011 FROM THE SALES REPRESENTATIVE STATED "SPOKE TO THE HEAD NURSE. ALL SHE TOLD ME WAS THAT THE PT WAS TAKEN BACK TO CCU (CARDIAC CARE UNIT). THE NURSE DID NOT KNOW PT OUTCOME AS OF YET." REFERENCE MDR # 1219856-2011-00242 FOR THE THIRD EVENT INVOLVING THE SAME PT.

    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 KF1049737

    Patients

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