BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 2102951 · Received May 4, 2011

    Report

    Report Number
    1219856-2011-00154
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 29, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) WAS SCHEDULED FOR A "PREOPERATIVE" INSERTION. WHILE IN THE CATH LAB THE IAB WAS PREPARED CORRECTLY AND ZEROED PRIOR TO INSERTION. THE IAB WAS INSERTED THROUGH A SHEATH VIA THE LEFT FEMORAL ARTERY. DIRECTLY AFTER INSERTION AND PLACEMENT OF THE TIP IN THE AORTA, NO AORTA PRESSURE WAS VISIBLE. THE PRESSURE LINE WAS FLAT. AS A RESULT, THE IAB WAS REMOVED AND A SECOND IAB WAS PREPPED AND INSERTED WITHOUT INCIDENT. THE SECOND IAB "WORKED FINE AND PRESSURE WAS VISIBLE." THE INTRA-AORTIC BALLOON PUMP (IABP) THERAPY WAS DELAYED/INTERRUPTED FOR 10 MINUTES. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WERE NO REPORTED PT COMPLICATIONS. THE PT OUTCOME IS OK, HE IS STILL IN THE CARDIAC CARE UNIT AT THIS TIME.

    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 KF1039444

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR INTRA-AORTIC BALLOON PUMP