BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 7.5 FR - 30 CC

    MDR report key: 1994261 · Received January 14, 2011

    Report

    Report Number
    1219856-2011-00004
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 7, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 A FEMALE PT AGE (B)(6) YEARS OLD WAS HAVING AN INTRA-AORTIC BALLOON (IAB) INSERTED IN THE CATH LAB. THE IAB WAS PREPPED PER THE INSTRUCTIONS FOR USE AND THE LEFT FEMORAL ARTERY WAS ACCESSED USING THE TEFLON SHEATH. THE PT DID NOT HAVE TORTUOUS OR CALCIFIED VESSELS. THE IAB WAS INSERTED WITHOUT INCIDENT AND WHEN THE PUMP WAS STARTED, IT "HIGH PRESSURE ALARMED" AND BLOOD MADE ITS WAY BACK INTO THE IAB TUBING. THE IAB WAS REMOVED WITH THE TEFLON SHEATH LEFT INTACT AND A NEW IAB WAS INSERTED. THERE WAS NO PT DEATH, INJURIES OR COMPLICATIONS. THE PT OUTCOME WAS LISTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 7.5 FR - 30 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTERNATIONAL INC MF9067352

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK