BEUDAMED
    FDA Adverse Event Death Summary report: N

    IAB : 8 FR - 30 CC FOS

    MDR report key: 1893322 · Received October 29, 2010

    Report

    Report Number
    1219856-2010-00768
    Event Type
    Death
    Date Received
    October 29, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Adverse Event
    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 INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED "AROUND (B)(6) 2010. AN (B)(4) SERIES LWS CATHETER WAS USED AND WHEN THE CATHETER WAS INSERTED INTO THE SUPER ARROW-FLEX (SAF) SHEATH, THE CATHETER STUCK IN THE SAF SHEATH." THERE WAS A REPORTED PATIENT DEATH. "IT IS UNKNOWN IF THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH." THE EVENT IS "STILL UNDER INVESTIGATION." IT IS UNKNOWN IF SURGICAL/MEDICAL INTERVENTION WAS USED. THE INSERTION SITE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR - 30 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. MF9088680

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death