BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 144586 · Received January 15, 1998

    Report

    Report Number
    2248146-1998-00013
    Event Type
    Malfunction
    Date Received
    January 15, 1998
    Date of Event
    December 31, 1997
    Report Date
    January 6, 1998
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE MEMBRANE. UNDER MICROSCOPY, A PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. PROBABLE CAUSE OF DIFFICULTY: THE RAGGED EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.

    Description of Event or Problem · 1

    EVENT: (CC# 98-00013) AFTER IABP FOR TWENTY HOURS, BLOOD WAS NOTED IN THE TUBING. ON 2/9/1998, THE FOLLOWING INFO WAS REPORTED TO DATASCOPE: THE IAB WAS INSERTED INTO THE PT ON 12/30/1997. ON 12/13/1997 AFTER IABP FOR 20 HOURS, BLOOD WAS NOTED IN THE TUBING. [EVENT COMPLICATONS]: NONE FROM THE EVENT - REPORTED 1/6/1998, 2/9/1998. [PT'S CURRENT STATUS]: HEALTHY-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 0784-00-0126 10/25/1999

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR