BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 2141175 · Received June 22, 2011

    Report

    Report Number
    1219856-2011-00211
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 17, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REFERENCE MDR # 1219856-2011-00210 FOR THE FIRST EVENT INVOLVING THE SAME PATIENT. IT WAS REPORTED THAT THE PROCEDURE WAS BEING PERFORMED ON AN APPROX (B)(6) OLD MALE PATIENT. A NEW KIT WAS OPENED AND THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER THE INSTRUCTIONS FOR USE. THE SYRINGE WAS REMOVED LEAVING THE VALVE INTACT. THE FIBER OPTIX SENSOR (FOS) WAS CONNECTED TO THE INTRA-AORTIC BALLOON PUMP (IABP) WHICH LITE APPROPRIATELY. THEN THE CATHETER WAS INSERTED INTO THE LEFT FEMORAL ARTERY VIA THE TEFLON SHEATH, AT WHICH TIME THE PUMP WAS STARTED AND AN ALARM OCCURRED THAT THERE WAS A LEAK. THEY REMOVED BOTH THE SHEATH AND IAB AS ONE AND IN THE PROCESS THE FEMORAL ARTERY BECAME INJURED. THE FEMORAL ARTERY REQUIRED SURGICAL REPAIR. THE PATIENT WAS TREATED WITH INOTROPIC SUPPORT AND DID OKAY. THERE WAS A DELAY IN TREATMENT WITH NO PATIENT DEATH. THE PATIENT WAS DISCHARGED A FEW DAYS LATER WITH NO OTHER COMPLICATIONS.

    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 KR1039568

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention