BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 1856696 · Received September 10, 2010

    Report

    Report Number
    1219856-2010-00599
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 23, 2010
    Report Date
    September 3, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    UNKNOWN

    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 WHILE IN THE CATH LAB THE MD INSERTED A SUPER ARROW-FLEX (SAF) SHEATH WITH DILATOR. THE MD INSERTED THE INTRA-AORTIC BALLOON (IAB) INTO THE SAF SHEATH AND THE BALLOON STOPPED ADVANCING AND STUCK IN THE SAF SHEATH. THE MD TRIED TO ADVANCE THE BALLOON CATHETER, BUT HE COULD NOT PASS IT THROUGH THE SAF SHEATH DUE TO CRITICAL RESISTANCE. AS A RESULT, THE MD HAD TO REMOVE THE SAF SHEATH AND BALLOON CATHETER TOGETHER. A NEW IAB-05840-U WAS OPENED AND IN THE SAME INSERTION SITE (LEFT FEMORAL ARTERY) THE MD INSERTED THE NEW SAF SHEATH AND CATHETER AND FINISHED THE CATHETERIZATION. THERE WAS NO REPORTED PATIENT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WAS A DELAY IN THERAPY OF 10 MINUTES. THERE WAS NO EXCESSIVE BLEEDING DURING THE PROCEDURES. THE PATIENT OUTCOME IS LISTED AS "THE PATIENT DOES NOT HAVE ANY COMPLICATIONS AND IS FINE."

    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. MF9100025

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK