BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 1963640 · Received December 21, 2010

    Report

    Report Number
    1219856-2010-00906
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 9, 2010
    Report Date
    December 21, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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

    REFERENCE MDR #1219856-2010-00905 FOR THE FIRST EVENT AND MDR #1219856-2010-00913 FOR THE THIRD EVENT INVOLVING THE SAME PT. IT WAS REPORTED THAT THE PT WAS SCHEDULED FOR SURGERY AND THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED IN THE OPERATING ROOM. THE MD INSERTED THE TEFLON SHEATH INTO THE PATIENT'S LEFT FEMORAL ARTERY. THE MD INSERTED THE IAB THROUGH THE TEFLON SHEATH AND INTO PLACE. WHEN REMOVING THE SPRING WIRE GUIDE (SWG) FROM THE IAB THE SWG BECAME STUCK IN THE IAB. AS A RESULT, THE MD REMOVED THE IAB, SWG, AND SHEATH AS ONE UNIT. THE MD MADE A REQUEST FOR ANOTHER IAB. THERE WAS NO REPORTED PATIENT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THE MD REQUESTED ANOTHER IAB FOR THE INSERTION.

    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 INTL., INC. KF0087858

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR