BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 2141154 · Received June 22, 2011

    Report

    Report Number
    1219856-2011-00210
    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). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE PROCEDURE WAS BEING PERFORMED ON AN APPROXIMATELY (B)(6) MALE PATIENT . PRIOR TO INSERTION, THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER THE INSTRUCTIONS FOR USE AND THE SYRINGE WAS REMOVED. THE FIBER OPTIX SENSOR (FOS) WAS CONNECTED TO THE INTRA-AORTIC BALLOON PUMP (IABP), LIGHTING APPROPRIATELY. THE CATHETER WAS THEN INSERTED INTO THE RIGHT FEMORAL ARTERY VIA THE TEFLON SHEATH. THE IAB BECAME CAUGHT IN THE TEFLON SHEATH, AT WHICH TIME THEY REMOVED BOTH THE SHEATH AND CATHETER AS ONE AND IN THE PROCESS THE FEMORAL ARTERY BECAME INJURED. THE FEMORAL ARTERY REQUIRED SURGICAL REPAIR. REFERENCE MDR #1219856-2011-00211 FOR THE SECOND EVENT INVOLVING THE SAME PATIENT.

    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