BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCOR STAT DL 9.5 FR. 40 CC IAB

    MDR report key: 116421 · Received August 30, 1997

    Report

    Report Number
    2248146-1997-00899
    Event Type
    Injury
    Date Received
    August 30, 1997
    Date of Event
    August 5, 1997
    Report Date
    August 6, 1997
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 PTON 8/4/97. ON 8/5/97 CHECK "IAB CATH" ALARM SOUNDED FROM THE PUMP AND BLOOD WAS NOTED IN THE TUBING. THE IAB WAS REMOVED AND A 34 CC IAB WAS INSERTED INTO THE PT LEFT GROIN IN THE O.R. AS A RESULT OF THE EVENT, THE PT FEMORAL ARTERY NEEDED TO BE REPAIRED. THE FOLLOWING WAS RPT'D TO CO ON 9/3/97: THE PUMP ALARMED "CHECK IAB CATHETER" AT 1510. THE NURSE NOTED BROWN FLECKS IN THE DRIVE LINE. SHE CALLED THE CVS LAB FOR CONSULTATION. THE LEAK WAS CONFIRMED AND THE PUMP WAS TURNED OFF. THE CARDIOLOGIST WAS CALLED. HE WAS UNABLE TO RESPOND UNTIL AFTER 1630. THE PT WAS BROUGHT TO THE O.R. AT 1720 FOR VASCULAR SURGICAL REMOVAL DUE TO VESSEL FRAILITY. A NEW 34 CC. IAB WAS INSERTED INTO THE PT AFTER THE FIRST IAB WAS REMOVED. THERE WERE NO FURTHER PROBLEMS. THIS IAB FUNCTIONED WELL. EVENT COMPLICATIONS: THE PT ARTERY NEEDED TO BE REPAIRED - RPT'D 8/6, 9/3/97. PT CURRENT STATUS: FINE - RPT'D 8/6/97, 9/3/97.

    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 CORPORATION 0684-00-0269 6/20/99

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention