BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 1662024 · Received April 9, 2010

    Report

    Report Number
    1219856-2010-00239
    Event Type
    Malfunction
    Date Received
    April 9, 2010
    Date of Event
    March 18, 2010
    Report Date
    April 7, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INCIDENT OCCURRED WITH THE "ON CALL TEAM." INDICATION FOR USE STEMI PATIENT. THE TECHNICIAN PREPPED THE INTRA-AORTIC BALLOON (IAB) PER INSTRUCTION AND MD INSERTED THE SUPER ARROW-FLEX (SAF) SHEATH INTO THE PATIENT'S FEMORAL ARTERY. AS THE IAB WAS INSERTED THROUGH THE SAF SHEATH, THE MD MET RESISTANCE. THE IAB WAS UNABLE TO BE ADVANCED THROUGH THE SAF SHEATH AND AS A RESULT, THE MD REMOVED THE IAB AND SAF SHEATH AS ONE UNIT. ANOTHER IAB-05840-LWS WAS PREPPED AND INSERTED THROUGH A NEWLY INSERTED SAF SHEATH WITHOUT INCIDENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS OR SIGNIFICANT DELAY IN TREATMENT. THE CATH LAB MANAGER STATED THAT THE SECOND IAB WAS INSERTED SUCCESSFULLY.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK