BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 180753 · Received August 1, 1998

    Report

    Report Number
    2248146-1998-00851
    Event Type
    Malfunction
    Date Received
    August 1, 1998
    Report Date
    July 17, 1998
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-00899) THE DOCTOR WAS UNABLE TO INSERT THE IAB THROUGH THE SHEATH. WHEN REMOVING THE IAB FROM THE TRAY, THE DOCTOR ASPIRATED AIR FROM THE MEMBRANE, BUT THEN TOOK OFF THE ONE-WAY VALVE DURING THE INSERTION ATTEMPT. THE DOCTOR INSERTED ANOTHER IAB THROUGH THE SAME SHEATH WITH DIFFICULTY. THE FOLLOWING WAS REPORTED TO DATASCOPE ON 8/28/98: THE MEMBRANE BECAME UNWRAPPED DURING INSERTION. THE IAB WAS REMOVED AND ANOTHER WAS INSERTED WITHOUT A PROBLEM. THERE WAS NO PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. [EVENT COMPLICATIONS]: NONE FROM THE EVENT - REPORTED 7/17/98 AND 8/28/98. [PATIENT'S CURRENT STATUS]: UNK - REPORTED 7/17 & 8/28.

    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 0684-00-0306 06/18/00

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN