BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 144579 · Received January 15, 1998

    Report

    Report Number
    2248146-1998-00012
    Event Type
    Malfunction
    Date Received
    January 15, 1998
    Date of Event
    January 1, 1998
    Report Date
    January 6, 1998
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABEL CODE FOR F10. POSITION 1: 1738. DEVICE LABEL CODE FOR F10. POSITION 2: 1701. DEVICE LABEL CODE FOR F10. POSITION 3: 1738.

    Description of Event or Problem · 1

    EVENT: (CC# 98-00012) UPON INSERTION OF THE IAB, THE BALLOON WOULD NOT PASS THE BIFURATION. AFTER SEVERAL ATTEMPTS TO ADVANCE THE IAB, IT WAS REMOVED THROUGH THE SHEATH AND A SECOND IAB WAS INSERTED WITHOUT DIFFICULTY USING THE SAME SHEATH. THE FOLLOWING WAS REPORTED TO DATASCOPE ON 2/20/1998: THERE WAS NO PT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. [EVENT COMPLICATION]: NONE FROM THE EVENT - REPORTED 1/6/1998 AND 2/20/1998. [PT'S CURRENT STATUS]: UNKNOWN - RPT'D 1/6/1998.

    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 CORPORATION 0684-00-0283 10/22/1999

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN