BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCOR STAT DL 9.5 FR. 40 CC IAB

    MDR report key: 116395 · Received August 30, 1997

    Report

    Report Number
    2248146-1997-00903
    Event Type
    Injury
    Date Received
    August 30, 1997
    Date of Event
    August 3, 1997
    Report Date
    August 7, 1997
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE IAB WAS INSERTED INTO THE PT ON 7/29/97. ON 8/3/97, THE IAB LEAKED. THE DR WAS UNABLE TO REMOVED THE IAB FROM THE PT. THE IAB WAS ENTRAPPED AND NEEDED TO BE SURGICALLY REMOVED. THE FOLLOWING WAS RPT'D TO CO ON 9/3/97: THE RN NOTED BLOOD IN THE BALLOON GAS LINE ON 8/2/97. BLOOD INCREASED AND THE BALLOON WAS SURGICALLY REMOVED ON 8/3/97. THE BALLOON HAD LARGE BLOOD CLOTS INSIDE AND OUT. AS A RESULT OF THE EVENT, THE PT REQUIRED A FEMORAL CUTDOWN, EMBOLECTOMY, AND ARTERIAL GRAFT. AFTER THE EVENT, THE PT REMAINED IN SERIOUS CONDITION IN THE CRITICAL CARE UNIT. EVENT COMPLICATIONS: THE IAB WAS ENTRAPPED/SURGICALLY REMOVED - RPT'D 8/7/97, 9/3/97. PT CURRENT STATUS: CRITICAL - RPT'D 8/7, 9/3/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCOR STAT DL 9.5 FR. 40 CC IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION 0684-00-0283 07/10/99

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention