BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 180756 · Received August 1, 1998

    Report

    Report Number
    2248146-1998-00850
    Event Type
    Malfunction
    Date Received
    August 1, 1998
    Date of Event
    July 8, 1998
    Report Date
    July 10, 1998
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-00898) THE DOCTOR HAD DIFFICULTY INSERTING THE IAB INTO THE PATIENT OF 7/8/98 AT 7:15 P.M. THE IAB WAS REMOVED ON 7/8/98 AT 8:45 P.M. A SECOND IAB WAS INSERTED INTO THE PATIENT. THE PATIENT HAD BLEEDING THAT WAS NOT SEVERE. THE IAB WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. ON 8/11/98 DATASCOPE WAS NOTIFIED THE IAB WAS AVAILABLE FOR EVALUATION. ON 8/28/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: THE PATIENT WAS TAKEN TO THE CATHETER LAB AFTER IAB INSERTION AT BEDSIDE IN CCU. FLUROSCOPY VERIFIED BALLOON PLACEMENT TO BE LOW. THE BALLOON COULD NOT BE ADVANCED MANUALLY OR BY PLACING A WIRE THROUGH THE CENTRAL LUMEN. THE IAB WAS LOW AND OCCLUDING THE RENALS. THE IAB WAS REMOVED AND ANOTHER IAB WAS INSERTED WITHOUT DIFFICULTY. THERE WAS NO PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT ON 7/8/98. IT WAS REPORTED THAT THE PATIENT EXPIRED ON 7/9/98 AFTER CABG SURGERY. [EVENT COMPLICATIONS]: BLEEDING/NOT SEVERE - REPORTED 7/10/98. [PATIENT'S CURRENT STATUS]: EXPIRED - REPORTED 7/10/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 40 CC. IAB INTRA-OARTIC BALLOON CATHETER DSP DATASCOPE CORPORATION 0684-00-0269 05/02/00

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR