BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 1944022 · Received December 3, 2010

    Report

    Report Number
    1219856-2010-00886
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    August 9, 2010
    Report Date
    December 2, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE CATH LAB THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTIONS. WHEN THE CATHETER WAS INSERTED IN THE SUPER ARROW-FLEX (SAF) SHEATH IT BECAME STUCK. THE IAB AND SHEATH WERE REMOVED TOGETHER AND A NEW KIT WAS OPENED AND USED SUCCESSFULLY. THE SECOND INSERTION SITE WAS THE SAME AS THE FIRST, BUT THE LOCATION IS NOT KNOWN. THERE WAS NO PT DEATH, INJURIES OR COMPLICATIONS NOTED. THE PT'S OUTCOME IS LISTED AS 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 INTERNATIONAL INC MF9099312

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN