BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCOR STAT DL 9.5 FR. 40 CC IZB

    MDR report key: 70125 · Received February 14, 1997

    Report

    Report Number
    2248146-1997-00102
    Event Type
    Malfunction
    Date Received
    February 14, 1997
    Report Date
    January 15, 1997
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: UNDERWATER LEAK TESTING DISCLOSED A LEAK IN THE BALLOON MEMBRANE. PROBABLE CAUSE OF DIFFICULTY: THE PENETRATION IS CHARACTERISTIC OF THAT PRODUCED WHEN THE MEMBRANE IS SUBJECTED TO NON-LINEAR OR BIAXIAL FOLDING. BIAXIAL FOLDING IS PRODUCED WHEN THE BALLOON IS SUBJECTED TO A NON-PREDICTABLE FOLDING PATTERN, AS WHEN IT ENTERS A SUBINTIMAL SPACE, IS LOCATED TOO HIGH IN THE AORTIC ARCH, OR ENTERS THE SUBCLAVIAN ARTERY.

    Description of Event or Problem · 1

    THE "BLOOD DETECTED" ALARM SOUNDED AND CONTINUED TO SOUND FROM THE SYSTEM 97 PUMP SO THE IAB WAS REMOVED. (EVENT COMPLICATIONS: UNKNOWN - REPORTED 1/15/97; NONE REPORTED 2/3/97.) (PT'S CURRENT STATUS: UNK - RPT'D 1/15/97.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCOR STAT DL 9.5 FR. 40 CC IZB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0784-00-0108-11 08/24/98N

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN