BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSATION PLUS 8FR 50CC

    MDR report key: 4092337 · Received September 2, 2014

    Report

    Report Number
    2248146-2014-00370
    Event Type
    Death
    Date Received
    September 2, 2014
    Report Date
    August 4, 2014
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K112327
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND LOT INFORMATION WAS NOT AVAILABLE, THE CUSTOMER SHIPPING HISTORY WAS REVISED TO DETERMINE THE MOST LIKELY LOT(S) INVOLVED IN THIS EVENT. A LOT HISTORY REVIEW WAS PERFORMED FOR THOSE LOTS AND NO NON-CONFORMANCES WERE FOUND THAT ARE RELATED TO THE EVENT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DIFFICULTY INSERTING AN IAB CATHETER INTO A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PT. A SECOND IAB WAS USED TO COMPLETE THE PROCEDURE. IT WAS LATER REPORTED THAT THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532585 SENSATION PLUS 8FR 50CC INTRA AORTIC BALLOON CATHETER DSP DATASCOPE CORP 0684-00-0575

    Patients

    Seq Age Sex Outcome Treatment
    1 Death