BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 188363 · Received September 16, 1998

    Report

    Report Number
    2248146-1998-01007
    Event Type
    Malfunction
    Date Received
    September 16, 1998
    Date of Event
    August 26, 1998
    Report Date
    August 31, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-01070) THE IAB LEAKED UPON INSERTION. THE IAB WAS REMOVED AND A SECOND IAB WAS INSERTED INTO THE PATIENT. (MULTIPLE EVENT TO CUSTOMER COMPLAINT NUMBER 98-01071) ON 10/26/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: DURING THE INSERTION OF THE IAB INTO THE PATIENT, THE IAB LEAKED ON INSERTION. A HOLE WAS NOTED IN THE CATHETER. THE IAB WAS REMOVED AND ANOTHER WAS INSERTED. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 8/31/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 8/31/98.

    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 05/21/00

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN