BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 118756 · Received September 9, 1997

    Report

    Report Number
    2248146-1997-00952
    Event Type
    Malfunction
    Date Received
    September 9, 1997
    Date of Event
    July 25, 1997
    Report Date
    August 18, 1997
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: UNDER WATER 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 7/22/97. ON 7/25/97, THERE WAS EVIDENCE OF DARK BROWN MATERIAL IN THE TUBING SUGGESTING A MIXTURE OF HELIUM AND BLOOD. A SPONTANEOUS LEAK TOOK PLACE AFTER FOUR DAYS OF IABP. THE IAB WAS REMOVED IMMEDIATELY AFTER ASPIRATION OF ALL AIR/HELIUM FROM THE LUMEN. NO SECOND IAB WAS INSERTED INTO THE PT. THE PT'S CONDITION BEFORE AND AFTER THE EVENT WAS CRITICAL. (DATASCOPE REC'D THIS REPORT ON 8/18/97 VIA THE MANDATORY MEDWATCH FORM FROM THE USER FACILITY; UF/DIST REPORT NUMBER: 070022-1997-0009). THE FOLLOWING WAS REPORTED TO DATASCOPE ON 12/8/97: BLOODY FLUID WAS NOTED TO BE WITHIN THE IAB TUBING. THERE WAS NO PT INJURY OR COMPLICATION AS A RESULT OF THE EVENT ON 7/25/97. THE PT WENT ON TO EXPIRE ON 7/29/97 BUT THE PT'S DEATH WAS NOT DIRECTLY RELATED TO THE IAB EVENT. [EVENT COMPLICATIONS]: NONE FROM THE EVENT-REPORTED 8/18/97 AND 12/8/97. [PT'S CURRENT STATUS]: EXPIRED ON 7/29/97.

    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 06/20/99

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR