BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSATION PLUS 8FR 50CC

    MDR report key: 4092317 · Received September 2, 2014

    Report

    Report Number
    2248146-2014-00375
    Event Type
    Death
    Date Received
    September 2, 2014
    Date of Event
    July 17, 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
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR RETURN AND NO LOT INFORMATION WAS PROVIDED, THEREFORE, NO EVALUATION CAN BE PERFORMED TO CONFIRM THE REPORTED EVENT. IF THE DEVICE IS RETURNED OR ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING DIFFICULTY GETTING THE IAB THROUGH THE SHEATH. ANOTHER 50CC IAB WAS INSERTED WITH ISSUE. THE CUSTOMER LATER REPORTED THAT THE PT EXPIRED, HOWEVER, IT WAS NOT RELATED TO THE REPORTED EVENTS. RELATED TO MFR REPORT #2248146-2014-00374.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533058 SENSATION PLUS 8FR 50CC INTRA AORTIC BALLOON` DSP DATASCOPE CORP 0684-00-0575

    Patients

    Seq Age Sex Outcome Treatment
    1 Death