BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCOR STAT DL 9.5 FR 40 CC IAB

    MDR report key: 122327 · Received September 24, 1997

    Report

    Report Number
    2248146-1997-01014
    Event Type
    Malfunction
    Date Received
    September 24, 1997
    Date of Event
    September 11, 1997
    Report Date
    September 11, 1997
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABEL CODE FOR F10. POSITION 1: 1701. POSITION 2: 1738. EVALUATION: THE IAB WAS RECEIVED INTACT FOR EVALUATION WITH A MODERATE AMOUNT OF BLOOD NOTED TO BE WITHIN THE MEMBRANE AND CATHETER TUBING. THE SHEATH TUBING WAS NOTED TO BE SEVERELY KINKED ALONG ITS LENGTH. NO LEAK WAS FOUND IN THE INNER LUMEN. UNDERWATER LEAK TESTING REVEALED NUMEROUS LEAKS IN THE MEMBRANE. VISUAL EXAMINATION REVEALED SMOOTH-EDGED TEARS IN THE MEMBRANE. THE PRIMARY BALLOON PENETRATION COULD NOT BE LOCATED. PROBABLE CAUSE OF DIFFICULTY: BASED ON THE POOR CONDITION OF THE RETURNED IAB, IT WAS NOT POSSIBLE TO LOCATE THE PRIMARY PENETRATION WHICH ALLOWED BLOOD TO ENTER THE DEVICE. IT IS POSSIBLE THAT THE DAMAGE TO THE BALLOON MEMBRANE OBSCURED THE PRIMARY PENETRATION.

    Description of Event or Problem · 1

    EVENT: (CC# 97-01032) AFTER IABP FOR ABOUT TWO HOURS, "CHECK IAB CATH" ALARM SOUNDED FROM THE PUMP AND THE IAB LEAKED AND WAS REMOVED FROM THE PT. THE FOLLOWING WAS REPORTED TO DATASCOPE ON 10/3/1997: THE PT HAD CABG ON 9/11/1997. FOLLOWING CABG, THE PT WAS HEMODYNAMICALLY UNSTABLE. THE IAB WAS INSERTED IN THE O.R. AT APPROXIMATELY 12:30 PM. TWO HOURS LATER, THE CATHETER LEAKED AND WAS REMOVED AT 3:30 PM ON 9/11/1997. THE PT REMAINED IN CRITICAL CONDITION. (ON 6/17/1998, DATASCOPE RECEIVED THE VOLUNTARY MEDWATCH FROM THE FDA; MDR ACCESS NUMBER 1013816) [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 9/11/1997; NONE - REPORTED 10/3/1997. [PT'S CURRENT STATUS]: STABLE - RPT'D 10/3/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCOR STAT DL 9.5 FR 40 CC IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0283 08/01/99

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR