BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 140513 · Received December 24, 1997

    Report

    Report Number
    2248146-1997-01386
    Event Type
    Malfunction
    Date Received
    December 24, 1997
    Date of Event
    December 4, 1997
    Report Date
    December 10, 1997
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE BALLOON MEMBRANE. PROBABLE CAUSE OF DIFFICULTY: THE PENETRATION IS CHARACTERISTIC OF THAT PRODUCED WHEN THE MEMBRANE IS SUBJECTED TO NON-LINEAR OR BIAXIAL FOLDING. BIAXIAL FOLDING IS PRODUCED WHEN THE BALLOON IS SUBJECTED TO A NON-PREDICTABLE FOLDING PATTERN, AS WHEN IT ENTERS A SUBINTIMAL SPACE, IS LOCATED TOO HIGH IN THE AORTIC ARCH, OR ENTERS THE SUBCLAVIAN ARTERY

    Description of Event or Problem · 1

    EVENT: (CC# 97-01487) AFTER IABP FOR SEVERAL HOURS, THE IAB LEAKED. BLOOD WAS NOTED IN THE TUBING AND THE IAB WAS REMOVED. A SECOND IAB WAS INSERTED INTO THE PT. ON 1/15/1998, DATASCOPE RECEIVED THE VOLUNTARY MEDWATCH FORM FROM THE FDA; TRIAGE UNIT SEQUENCE NUMBER: 75243 AND THE FOLLOWING INFO WAS REPORTED: THE IAB RUPTURED WHILE IN THE PT. ON 1/19/1998, THE FOLLOWING WAS REPORTED TO DATASCOPE: BLOOD WAS SEEN IN THE CATHETER TUBING AND PUMPING WAS STOPPED. THE CATHETER WAS REMOVED AND A NEW IAB WAS INSERTED. [EVENT COMPLICATIONS]: NONE FROM THE EVENT - REPORTED 12/10/1997 AND 1/19/1998. [PT'S CURRENT STATUS]: DISCHARGED-RPT'D 1/19/1998.

    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 3/11/99

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR