BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8 FR - 40 CC FOS

    MDR report key: 1929908 · Received November 19, 2010

    Report

    Report Number
    1219856-2010-00843
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 19, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REFERENCE MDR #1219856-2010-00842 FOR THE FIRST EVENT INVOLVING THE SAME PATIENT. IT WAS REPORTED THAT WHILE IN THE CATH LAB THE MD INSERTED THE SUPER ARROW-FLEX (SAF) SHEATH INTO THE PATIENT'S FEMORAL ARTERY. UPON INSERTING THE INTRA-AORTIC BALLOON (IAB) THROUGH THE SAF SHEATH, THE MD FOUND THAT HE COULD NOT ADVANCE THE IAB ENTIRELY THROUGH THE SAF SHEATH, THE MD FOUND THAT HE COULD NOT ADVANCE THE IAB ENTIRELY THROUGH THE SAF SHEATH. AS A RESULT, IAB AND THE SAF SHEATH WERE REMOVED. THE MD INSERTED THE TEFLON SHEATH INTO THE SAME INSERTION SITE AND COMPLETED THE INSERTION. THERE WAS NO REPORTED PATIENT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WERE NO REPORTED PATIENT COMPLICATIONS. THE PATIENT IS CURRENTLY STILL RECEIVING IAB THERAPY.

    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 INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK