BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 183408 · Received August 18, 1998

    Report

    Report Number
    2248146-1998-00923
    Event Type
    Injury
    Date Received
    August 18, 1998
    Date of Event
    August 5, 1998
    Report Date
    August 6, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE IAB LEAKED. BLOOD WAS NOTED IN THE TUBING. THE DR HAD DIFFICULTY REMOVING THE IAB FROM THE PT AT THE PT'S BEDSIDE. THE IAB WAS CUT AND THE TIP WAS LEFT INSIDE THE PT. THE PT WAS TAKEN OFF ALL LIFE SUPPORTS AND WENT ON TO EXPIRE. THE CONTACT AT THE FACILITY REPORTED THAT THE PT'S DEATH WAS NOT ATTRIBUTED TO THE EVENT. ON 8/11/98, DATASCOPE WAS NOTIFIED THAT THE IAB WOULD NOT BE RETURNED FOR EVAL. THE PT EXPIRED WITH PART OF THE IAB IN PLACE. ON 8/12/98. DATASCOPE WAS INFORMED THAT A PORTION OF THE IAB WOULD BE RETURNED FOR EVAL. THE FOLLOWING WAS REPORTED TO DATASCOPE ON 8/21/98: THE NURSE AT BEDSIDE NOTED A SMALL AMOUNT OF BLOOD IN THE CATHETER TUBING. PUMPING WAS STOPPED AND THE DR WAS NOTIFIED. THE DR ARRIVED WITHIN 15 MINS. HE WAS UNABLE TO REMOVE THE CATHETER. THE IAB WAS ENTRAPPED. DUE TO THE PT PLAN (TO DISCONTINUE LIFE SUPPORT ON 8/5/98), THE CATHETER WAS CUT AND THE TIP REMAINED IN THE PT. THE PT EXPIRED ON 8/5/98. (ON 8/21/98, DATASCOPE REC'D THE MEDWATCH FORM FROM THE USER FACILITY; UF/DIST REPORT NUMBER: 14-0258-1998-0150). [EVENT COMPLICATIONS]: ENTRAPPED/CUT IAB/TIP REMAINED IN PT-RPT'D 8/6/98. [PT'S CURRENT STATUS]: EXPIRED-RPT'D 8/6/98.

    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. 0684-00-0321 06/04/00

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention