BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCOR STAT DL 9.5 FR 40 CC IAB

    MDR report key: 118885 · Received September 9, 1997

    Report

    Report Number
    2248146-1997-00954
    Event Type
    Malfunction
    Date Received
    September 9, 1997
    Date of Event
    August 16, 1997
    Report Date
    August 20, 1997
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: UNDERWATER LEAK TESTING DISCLOSED MULTIPLE LEAKS IN THE IAB MEMBRANE. UNDER MICROSCOPY, A SMOOTH-EDGED PENETRATION WAS SEEN AT EACH LEAK SITE. PROBABLE CAUSE OF DIFFICULTY: THE PHYSICAL EVIDENCE INDICATES THAT THE SOURCE OF THE BALLOON LEAKS WERE PENEETRATIONS OF THE MEMBRANE PROBABLY CAUSED BY CONTACT WITH A SHARP EDGED OBJECT. THE MEMBRANE DAMAGE MAY HAVE OCCURRED PRIOR TO OR DURING BALLOON INSERTION.

    Description of Event or Problem · 1

    DURING INSERTION, BLOOD WAS NOTED IN THE TUBING. THE IAB WAS REMOVED AND A SECOND WAS INSERTED. THE FOLLOWING WAS REPORTED TO DATASCOPE ON 9/12/97: FIVE MINUTES AFTER IAB INSERTION, THE EXTRACORPOREAL TUBING FILLED WITH BLOOD. THE CONSOLE ALARMED "HIGH PRESSURE". ON 9/16/97, DATASCOPE RECEIVED THE VOLUNTARY MEDWATCH FORM FROM THE FACILITY; TRIAGE UNIT SEQUENCE NUMBER: 68754; MDR ACCESS NUMBER: 1011928. THE FOLLOWING WAS REPORTED TO DATASCOPE ON 9/16/97: THE IAB WAS INSERTED UNDER FLUOROSCOPY. FIVE MINUTES AFTER INSERTION, BLOOD FILLED THE EXTRA-CORPORAL TUBING OF THE BALLOON CATHETER. THE PUMP CONSOLE WAS TURNED OFF AND THE IAB WAS REMOVED. A SECOND IAB WAS INSERTED INTO THE PATIENT. THE PATIENT IS CURRENTLY STABLE. EVENT COMPLICATIONS: UNK - REPORTED 8/20/97; NONE - RPT'D 8/16/97, 9/12/97. PT CURRENT STATUS: STABLE RPT'D 8/16, 9/12/97.

    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. 0684-00-0321 5/1/99

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR