BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCOR STAT DL 9.5 FR. 40 CC IAB

    MDR report key: 108556 · Received July 25, 1997

    Report

    Report Number
    2248146-1997-00751
    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 (VASCULAR AND HEMORRHAGIC COMPLICATIONS). THE STUDY INVOLVED A MULTI HOSP IAB STUDY. A TOTAL OF 182 PTS WERE INVOLVED. THE INFO WAS REPORTED IN THE 1997 ISSUE OF "THE AMERICAN JOURNAL OF CARDIOLOGY"; VOLUME 79: PAGES 590-594. THE IAB IN QUESTION WERE NOT RETURNED TO DATASCOPE. THIS IS A LITERATURE REFERENCE ONLY. (ATTACHED IS A COPY OF THE LITERATURE REFERENCE) (EVENT COMPLICATION: VASCULAR AND HEMORHAGIC COMPLICATIONS.) (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