BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCOR STAT DL 9.5 FR. 40 CC IAB

    MDR report key: 108567 · Received July 25, 1997

    Report

    Report Number
    2248146-1997-00750
    Event Type
    Injury
    Date Received
    July 25, 1997
    Report Date
    June 30, 1997
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE QUALITY ASSURANCE DEPARTMENT OF DATASCOPE CORPORATION'S CARDIAC ASSIST DIVISION BECAME AWARE OF BALLOON EVENTS INVOLVING PT COMPLICATIONS (EXCESSIVE BLEEDING, THROBECTOMY, BLOOD TRANSFUSION) WHICH OCCURRED BETWEEN 10/89 AND 10/92. THE STUDY INVOLVED A MULTI-HOSPITAL IAB STUDY. A TOTAL OF 182 PTS WERE INVOLVED. THE INFO WAS REPORTED IN THE 1994 ISSUE OF "CIRCULATION"; VOLUME 90: PAGES 792-799. THE IABS IN QUESTION WERE NOT RETURNED TO DATASCOPE. THIS IS A LITERATURE REFERENCE ONLY. (EVENT COMPLICATION: EXCESSIVE BLEEDING/TRANSFUSION/THROMBECTOMY.) (PT'S CURRENT STATUS: UNKNOWN.)

    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 CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| R