BEUDAMED
    FDA Adverse Event Death Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 167969 · Received May 14, 1998

    Report

    Report Number
    2248146-1998-00531
    Event Type
    Death
    Date Received
    May 14, 1998
    Date of Event
    May 7, 1998
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 10/13/98.

    Description of Event or Problem · 1

    EVENT: (CC# 98-00563) THE DOCTOR WAS UNABLE TO DEFLATE THE IAB. THE CONTACT STATED THAT THE "IAB DID NOT WORK ALL DAY". THE PATIENT WAS IN CARDIOGENIC SHOCK AND LABILE. A GUIDEWIRE WAS PLACED THROUGH THE CENTRAL LUMEN WITHOUT A PROBLEM AND THEN FLUOROSCOPY WAS USED TO CHECK THE POSITION WHEN IT WAS NOTED THAT THE IAB WAS NOT DEFLATED AND THERE APPEARED TO BE A CLOT IN THE IAB. ATTEMPTS TO ASPIRATE HELIUM THROUGH THE GAS SHUTTLE LUMEN WAS UNSUCCESSSFUL. THE EXTRACORPOREAL TUBING WAS CUT AND AN ATTEMPT WAS MADE TO TRY TO ASPIRATE HELIUN WITHOUT SUCCESS. ON 5/8/98, DATASCOPE WAS NOTIFIED THAT THE IAB WAS FINALLY SURGICALLY REMOVED AND THE PATIENT WENT ON TO EXPIRE. ON 6/10/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: THE IAB BECAME ENTRAPPED. THE PATIENT WAS VERY UNSTABLE. THE PATIENT HAD TO BE INTUBATED. THE PATIENT EXPIRED ON 5/8/98. ON 9/18/98, THE FOLLOWING INFORMATION WAS REPORTED TO DATASCOPE: THE IAB WAS INSERTED INTO THE PATIENT ON 5/6/98 AT 6:45 P.M. ON 5/7/98 AT 2:00 P.M., POOR INFLATION AND AUGMENTATION WAS NOTED AND THE IAB WAS REMOVED ON 5/7/98 AT 9:00 P.M. THE PATIENT HAD MINOR ISCHEMIA AND A THROMBOSIS. THE PATIENT WENT ON TO EXPIRE ON 5/8/98 AT 12:10 P.M. THE FACILITY REPORTED THAT THE PATIENT'S DEATH WAS A DIRECT CONSEQUENCE OF THE IAB OR IAB THERAPY. [EVENT COMPLICATIONS]: ENTRAPPED/SURGICALLY REMOVED/DEATH - REPORTED 5/8/98. [PATIENT'S CURRENT STATUS]: EXPIRED-RPT'D 5/8/98.

    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 4/4/00

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death