BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 30 CC FOS

    MDR report key: 2266071 · Received September 8, 2011

    Report

    Report Number
    1219856-2011-00317
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    August 29, 2011
    Report Date
    September 1, 2011
    Manufacturer
    ARROW INTERNATIONAL, LTD.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    Z-0792-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A MALE PT, (B)(6). ACCORDING TO THE EVENT, THE PT WAS VERY SICK. WHILE IN THE CATH LAB AND AS THE PT WAS UNSTABLE AND CODING, THE SUPER ARROW-FLEX (SAF) SHEATH WAS INSERTED VIA THE PT'S FEMORAL ARTERY. AS THE MD WAS INSERTING THE INTRA-AORTIC BALLOON (IAB) INTO THE SAF SHEATH, THE IAB BECAME STUCK IN THE SAF SHEATH. THE IAB WOULD NOT PASS THROUGH THE SAF SHEATH; THE PROXIMAL END OF THE IAB MEMBRANE WOULD NOT EXIT THE DISTAL TIP OF THE SAF SHEATH. THE IAB AND SAF SHEATH WERE REMOVED. ANOTHER IAB WAS PREPPED FOR INSERTION. THE IAB WAS EXCHANGED UTILIZING A .018 SWG FROM THE CATH LAB STOCK. AT THIS TIME THERE WAS NO REPORTED PT DEATH. INTRA-AORTIC BALLOON PUMP (IABP) THERAPY WAS DELAYED. THE COMPLICATIONS WERE "THE PT WAS UNSTABLE AND CODING SIMULTANEOUS TO THIS INSERTION ACTIVITY." REFERENCE MDR #1219856-2011-00318 FOR THE SECOND EVENT, INVOLVING THE SAME PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 30 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTERNATIONAL, LTD. MF0053022

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INTRA-AORTIC BALLOON PUMP