BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 191076 · Received October 10, 1998

    Report

    Report Number
    2248146-1998-01131
    Event Type
    Injury
    Date Received
    October 10, 1998
    Date of Event
    September 24, 1998
    Report Date
    September 28, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-01211) THE IAB WAS INSERTED INTO THE PATIENT ON 9/23/98. ON 9/24/98, AN ALARM SOUNDED FROM THE PUMP AND BLOOD WAS NOTED IN THE TUBING. THE IAB WAS SURGICALLY REMOVED. NO SECOND IAB WAS INSERTED. ON 10/16/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: THE IABP ALARM SOUNDED AND BLOOD WAS DETECTED IN THE TUBING. A SMALL AMOUNT OF BLOOD WAS VISIBLE IN THE TUBING. THE DOCTOR WAS NOTIFIED AND HE WAS UNABLE TO REMOVE THE IAB. A LEFT FEMORAL CUTDOWN WAS PERFORMED AND A DIRECT SUTURE OF THE FEMORAL ARTERY WAS DONE. A CLOT WAS VISIBLE IN THE IAB AND THE IAB WAS DISCONTINUED. ANOTHER BALLOON WAS NOTED INSERTED INTO THE PATIENT. AFTER THE IAB WAS REMOVED, THE PATIENT WAS MAINTAINED ON THE SAME MEDICATION AND DRIPS. THERE WAS NO CHANGE IN THE PATIENT'S VITAL SIGNS. THE PATIENT'S STATUS REMAINED UNCHANGED AFTER REMOVAL. [EVENT COMPLICATIONS]: THE IAB WAS SURGICALLY REMOVED - REPORTED 9/28/98. [PATIENT'S CURRENT STATUS]: IMPROVED-RPT'D 9/28/98.

    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 CORP. 0684-00-0283 04/04/00

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention