BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 167134 · Received May 8, 1998

    Report

    Report Number
    2248146-1998-00521
    Event Type
    Malfunction
    Date Received
    May 8, 1998
    Date of Event
    May 6, 1998
    Report Date
    May 6, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    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 THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP.

    Description of Event or Problem · 1

    THE IAB WAS INSERTED INTO THE PT ON 05/05/1998. ON 05/06/1998 AFTER IABP FOR ABOUT 12 HOURS, THE IAB LEAKED. 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 NO PT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. ANOTHER IAB WAS INSERTED ON 05/06/1998 BECAUSE THE PT WAS DOING POORLY. (EVENT COMPLICATIONS): NONE FROM THE EVENT - REPORTED 05/06/1998M 06/10/1998. (PT'S CURRENT STATUS): BEING WEANED - REPORTED 06/10/1998.

    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 CORP. 0684-00-0283 2/20/00

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR