BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 34 CC. IAB

    MDR report key: 173825 · Received June 19, 1998

    Report

    Report Number
    2248146-1998-00681
    Event Type
    Malfunction
    Date Received
    June 19, 1998
    Date of Event
    June 8, 1998
    Report Date
    June 8, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 7/28/98).

    Description of Event or Problem · 1

    THE IAB WAS INSERTED INTO THE PT WITH A SHEATH. INITIALLY, THE IAB WOULD NOT INFLATE. THE PUMP WAS CHANGED AND IABP CONTINUED WITHOUT ANY FURTHER PROBLEMS. THE IAB WAS NOT RETURNED TO DATASCOPE FOR EVAL. THE IAB WAS USED AND THEN DISCARDED. (MULTIPLE EVENT TO CUSTOMER COMPLAINT NUMBER 98-00714, 98-00715). ON 7/6/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: THE IAB WAS PLACED IN THE PT USING A SHEATH. A DIFFERENT PUMP CONSOLE WAS USED. THIS CATHETER DID NOT FAIL. THIS IAB PERFORMED WELL AND THEN WAS DISCARDED. THERE WAS NO PT INJURY OR COMPLICATION. THE PT WAS STABLE. ANOTHER IAB WAS NOT INSERTED INTO THE PT. [EVENT COMPLICATIONS]: NONE FROM THE EVENT-REPORTED 6/8/98 AND 7/6/98. [PT'S CURRENT STATUS]: STABLE-RPT'D 7/6/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 34 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0206-01 03/09/00

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR