BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 1675873 · Received April 23, 2010

    Report

    Report Number
    1219856-2010-00260
    Event Type
    Malfunction
    Date Received
    April 23, 2010
    Date of Event
    March 31, 2010
    Report Date
    April 23, 2010
    Manufacturer
    ARROW INTERNATIONAL 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 CARDIO CATH LAB, THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER THE INSTRUCTIONS FOR USE. THE MD INSERTED THE SUPPER ARROW-FLEX (SAF) SHEATH INTO THE PATIENT'S LEFT FEMORAL ARTERY AND AS SOON AS THE MD INSERTED THE IAB, HE "FELT SOMETHING LIKE UNUSUAL RESISTANCE INSIDE OF THE SAF SHEATH." THE IAB COULD NOT BE PASSED THROUGH THE SAF SHEATH'S TIP. BECAUSE THE IAB WAS STUCK IN THE SAF SHEATH, THE MD REMOVED THE IAB AND THE SAF SHEATH AS ONE UNIT. ANOTHER IAB WAS OPENED, PREPPED AND INSERTED WITHOUT INCIDENT. THE STAFF STATED THAT THEY USED THE SAME INSERTION SITE AND THERE WAS NO EXCESSIVE BLEEDING DURING INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTERNATIONAL INC. MF9046501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK