BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 1994259 · Received January 14, 2011

    Report

    Report Number
    1219856-2011-00005
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 27, 2010
    Report Date
    January 10, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    Z-0790/0793-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    UNKNOWN

    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 PT IS TRANSPLANT CANDIDATE. WHILE IN THE CATH LAB, THE MD INSERTED THE SUPER ARROW-FLEX (SAF) SHEATH INTO THE PT'S RIGHT FEMORAL ARTERY. THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED INTO THE SAF SHEATH AND COULD ONLY BE ADVANCED 2/3'S OF THE WAY THROUGH THE SAF SHEATH WHEN THE MEMBRANE BEGAN TO "WRAP UP" (BULGE). THE MD DECIDED TO REMOVE THE IAB AND SAF SHEATH. ANOTHER IAB WAS RETRIEVED. ADD'L INFO RECEIVED ON 12/29/2010, FROM THE SALES REP STATED THAT IT IS UNK IF THE MD REMOVED THE SPRING WIRE GUIDE WITH THE SAF SHEATH AND IAB. REFERENCE MDR #1219856-2010-00006 FOR THE SECOND EVENT INVOLVING THE SAME PT.

    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 MF0063441

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR