BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 191562 · Received October 10, 1998

    Report

    Report Number
    2248146-1998-01145
    Event Type
    Malfunction
    Date Received
    October 10, 1998
    Date of Event
    September 28, 1998
    Report Date
    September 29, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-01225) THE IAB KINKED. THE IAB WAS REMOVED AND A SECOND IAB WAS INSERTED INTO THE PATIENT. (MULTIPLE EVENT TO CUSTOMER COMPLAINT NUMBER 98-01226) ON 10/26/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: THE IAB WAS PLACED AND WAS APPARENTLY WORKING WELL. THERE WAS GOOD WAVEFORM AND NO PUMP ALARMS. HOWEVER, THE SURGEON WAS CONVINCED THAT THE IAB HAD DOUBLED OVER ON ITSELF BECAUSE HE WAS NOT ABLE TO PASS A GUIDE WIRE THROUGH THE INNER LUMEN. HE DECIDED TO REMOVE THE IAB AND INSERT ANOTHER. THERE WAS NO PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. THE PATIENT WAS FINALLY DISCHARGED FROM THE HOSPITAL. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 9/29/98; NONE - RPT'D 10/26/98. [PATIENT'S CURRENT STATUS]: DISCHARGED-RPT'D 10/26/98.

    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. 0684-00-0269 04/17/00

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR