BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 2150532 · Received June 22, 2011

    Report

    Report Number
    1219856-2011-00218
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 EVENT OCCURRED IN THE OPERATING ROOM. THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION PRIOR TO THE MD INSERTING THE TEFLON SHEATH INTO THE RIGHT SUBCLAVIAN ARTERY WITH SUCCESS. PCPS (PERCUTANEOUS CARDIOPULMONARY SUPPORT) WAS USED THROUGH THE RIGHT FEMORAL ARTERY AND THE LEFT FEMORAL ARTERY WAS CLOGGED SO THE RIGHT SUBCLAVIAN ARTERY WAS USED FOR THE IAB INSERTION. THE MD WANTED TO SEE IF THE IAB POSITION WAS RIGHT BY INFLATING AND DEFLATING THE BALLOON USING A SYRINGE. WHEN THE BALLOON WAS DEFLATED, BLOOD ENTERED THE BALLOON. AS A RESULT, THE IAB WAS REMOVED WITH THE TEFLON SHEATH AS ONE UNIT. A COMPETITORS 8 FR. ZEON IAB WAS USED AT THE SAME INSERTION SITE WITHOUT ISSUE. THERE WAS NO MEDICAL/SURGICAL INTERVENTION NEEDED. THERE WAS NO REPORT OF PATIENT DEATH, COMPLICATIONS OR INJURY. THE PATIENT'S OUTCOME IS GOOD.

    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. KF1019096

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN INTRA-AORTIC BALLOON, (B)(4)