BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC

    MDR report key: 1052961 · Received May 27, 2008

    Report

    Report Number
    1219856-2008-00255
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    December 5, 2007
    Report Date
    May 27, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K040801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS INITIALLY EVALUATED AND DETERMINED TO BE NON-REPORTABLE BASED UPON THE INFO PROVIDED. THE RETURNED DEVICE WAS RECEIVED AND SUBSEQUENTLY EVALUATED AND THE EVENT WAS DETERMINED TO BE REPORTABLE. EVAL: THE INTRA-AORTIC BALLOON (IAB) WAS NOT RETURNED. ONLY THE 6" ARTERIAL PRESSURE LINE WAS RETURNED. THERE WERE NO TRACES OF BLOOD ON THE RETUNED EXTENSION LINE. AFTER BLOCKING ALL OPENINGS ON THE STOPCOCK, WATER WAS INJECTED INTO IT. A LEAK WAS EVIDENT WHERE THE 6" TUBING CONNECTS TO THE STOPCOCK. THE PART WAS EXAMINED UNDER MAGNIFICATION AND A VOID IN THE GLUE WAS DETECTED AT THE STOPCOCK/TUBING JUNCTION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED ON THE PART. THERE WERE NO MFG ABNORMALITIES ESTABLISHED BETWEEN THE DHR & THE REPORTED COMPLAINT. THE POTENTIAL CAUSE OF THIS ISSUE IS MFG RELATED SINCE THE BONDING AT THE STOPCOCK/TUBING JUNCTION APPEARED TO BE INCOMPLETE. AN INTERNAL NONCONFORMANCE HAS BEEN INITIATED TO ADDRESS THIS ISSUE. MGMT WILL CONTINUE MONITORING COMPLAINT REPORTS FOR ANY TRENDS WHICH MAY OCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CATH LAB THE MD INSERTED THE INTRA-AORTIC BALLOON (IAB). AFTER THE INSERTION, THE EXTENSION TUBE WAS FLUSHED WITH SALINE SOLUTION. AT THAT TIME, A LEAK OCCURRED FROM THE EXTENSION TUBE. AS A RESULT, THE EXTENSION TUBING WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. MF7065747

    Patients

    Seq Age Sex Outcome Treatment
    1