BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 10.5 FR. 50 CC. IAB

    MDR report key: 167139 · Received May 8, 1998

    Report

    Report Number
    2248146-1998-00523
    Event Type
    Malfunction
    Date Received
    May 8, 1998
    Date of Event
    May 1, 1998
    Report Date
    May 6, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 07/08/1998). EVALUATION: 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 THEAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.

    Description of Event or Problem · 1

    THE IAB WAS INSERTED INTO THE PT ON 05/02/1998. ON 05/03/1998, BLOOD WAS NOTED IN THE TUBING AND THE IAB WAS REMOVED. NO SECOND IAB WAS INSERTED. THE FOLLOWING WAS REPORTED TO DATASCOPE ON 06/10/1998: THERE WAS ALSO POOR IAB AUGMENTATION. THERE WAS NO PT INJURY OR COMPLICATION AS A RESULT OF THE EVENT ON 05/01/1998. ANOTHER IAB WAS NOT INSERTED INTO THE PT. THE PT WAS IMPROVING AFTER THE EVENT. (EVENT COMPLICATIONS): NONE FROM THE EVENT - REPORTED 05/06/1998, 06/10/1998. (PT'S CURRENT STATUS): IMPROVING - REPORTED 06/10/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 10.5 FR. 50 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0194 9/30/98

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR