BEUDAMED
    FDA Adverse Event Death Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 128979 · Received October 28, 1997

    Report

    Report Number
    2248146-1997-01145
    Event Type
    Death
    Date Received
    October 28, 1997
    Date of Event
    September 17, 1997
    Report Date
    October 15, 1997
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. THE ITEM WAS DISCARDED BY THE HOSP.

    Description of Event or Problem · 1

    THE IAB WAS INSERTED INTO THE PT ON 9/16/97 AT 12:00 P.M. AND REMOVED ON 9/17/97 AT 7:30 P.M. THE IAB DID NOT MALFUNCTION. THE CONTACT STATED THAT THE IAB WAS DISCARDED BY THE FACILITY. A VASCULAR SURGEON WAS CONSULTED, THE PT HAD A THROMBOSIS AND SURGERY WAS REQUIRED. THE CONTACT STATED THAT THE PT WENT ON TO EXPIRE AND THE DEATH WAS NOT A DIRECT CONSEQUENCE OF THE IAB OR IAB THERAPY. ON 11/3/97, THE FOLLOWING INFO WAS REPORTED: THE IABP WAS INSERTED IN THE CATH LAB. THE PT WENT TO CVOR FOR VSD CLOSURE AND CABG X4. POST OPERATIVELY, THE PT REQUIRED MUCH INOTROPIC SUPPORT. THE PT RIGHT AND LEFT EXTREMITY BECAME COOL AND CYANOTIC. A VASCULAR SURGEON WAS CONSULTED AND FEM-FEM BYPASS WAS PERFORMED AT THE BEDSIDE. THE PT CONTINUED TO DETERIORATE AND EXPIRED ON 9/17/97 AT 1930. ON 10/15/97, THE CONTACT STATED THAT THE PT DEATH WAS NOT A DIRECT CONSEQUENCE OF THE IAB OR IAB THERAPY. ON 11/3/97, THE CONTACT STATED THAT AS A RESULT OF THE EVENT, THE PT WENT ON TO EXPIRE. THE IAB WAS NOT SAVED. EVENT COMPLICATIONS: THROMBOSIS/SURGERY - RPT'D 10/15/97; DEATH - RPT'D 11/3/97. PT CURRENT STATUS: EXPIRED - RPT'D 10/15/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 40 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION 0684-00-0283 3/25/99

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| L| R