BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 7.5 FR - 40 CC

    MDR report key: 2193429 · Received July 13, 2011

    Report

    Report Number
    1219856-2011-00245
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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 MD INSERTED THE SHEATH INTO THE PT'S FEMORAL ARTERY. WHILE FEEDING THE INTRA-AORTIC BALLOON (IAB) CATHETER OVER THE SPRING WIRE GUIDE (SWG) AND THROUGH THE SHEATH, THE MD EXPERIENCED RESISTANCE. AT THIS TIME, THE MD EXAMINED THE CATHETER AND OBSERVED A KINK IN THE CATHETER. THE MD REQUESTED A NEW IAB AND THIS IAB WAS INSERTED WITHOUT DIFFICULTY THROUGH THE SHEATH. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. A SHORT DELAY IN INTRA-AORTIC BALLOON PUMP (IABP) THERAPY WAS CAUSED WHILE OPENING THE NEW CATHETER. THERE WERE NO REPORTED PT COMPLICATIONS. THE PT IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 7.5 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTERNATIONAL INC KF1049814

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR