BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 1994269 · Received January 14, 2011

    Report

    Report Number
    1219856-2011-00007
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 10, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A MALE PT WITH A 90% OCCLUSION OF THE LEFT MAIN POST STEMI. THE RN PHONE THE HOTLINE BECAUSE THEY COULD NOT GET THE FIBEROPTIX SENSOR (FOS) TO ZERO DURING INSERTION. WHEN THE CLINICAL SUPPORT SPECIALIST (CSS) SPOKE TO THE RN, HE STATED THAT THEY HAD TRIED TO CONNECT THE FOS TWICE TO THE INTRA-AORTIC BALLOON PUMP (B)(4) AND GOT THE MESSAGE TO "CONNECT THE FOS CONNECTOR." THE CSS EXPLAINED THAT THIS COULD MEAN THE FOS WAS DAMAGED OR THE PUMP CONNECTION MIGHT BE DIRTY. THE CSS SUGGESTED, THEY TRY CONNECTING THE FOS TO ANOTHER PUMP. HOWEVER, THEY HAD ALREADY PULLED ANOTHER IAB CATHETER AND PREPPED IT FOR INSERTION. WHEN THEY MADE THE FOS CONNECTION TO THE PUMP, IT ZEROED APPROPRIATELY. THEY ARE PLACING THE CATHETER THROUGH AN 8 FR SHEATH (THEY ARE USING THEIR OWN SHEATH AND HAVE BEEN DOING SO FOR QUITE A WHILE). THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WERE NO REPORTED COMPLICATIONS. THE PT WAS ABLE TO RECEIVE IABP THERAPY SUCCESSFULLY. THE PT IS FINE.

    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 INTRA-AORTIC BALLOON PUMP