BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCOR STAT DL 9.5 FR. 34 CC IAB

    MDR report key: 104019 · Received July 3, 1997

    Report

    Report Number
    2248146-1997-00673
    Event Type
    Malfunction
    Date Received
    July 3, 1997
    Date of Event
    June 13, 1997
    Report Date
    June 17, 1997
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABEL CODE FOR F10. POSITION 1 AND 2: 1738. POSITION 3: 1701. 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 LEAKED. THIS WAS THE ONLY INFO AVAILABLE AT THE TIME OF THE RPT. ON 8/18/97, DATASCOPE RECEIVED THE MANDATORY MEDWATCH FORM FROM THE USER-FACILITY; UF/DIST RPT #17-0086-0003 AND THE FOLLOWING INFO WAS RPT'D: THE PT WAS ADMITTED TO THE HOSP. ON 6/10/97 WITH UNSTABLE ANGINA AND WHO UNDERWENT A MCR X5 PROCEDURE ON 6/12/97. THE IAB WAS INSERTED INTO THE PT ON 6/12/97. ON 6/13/97 AFTER IABP FOR 40 HRS, ALARMS SOUNDED FROM THE PUMP AND IT WAS NOTED THAT THERE WAS BLOOD IN THE IAB CATHETER. THE IAB WAS REMOVED AND A SECOND WAS INSERTED WITH NO ADVERSE EFFECTS TO THE PT. EVENT COMPLICATIONS: UNK - RPT'D 6/17/97, 7/3/97; NONE - RPT'D 8/18/97. PT CURRENT STATUS: UNK - RPT'D 6/17, 8/18/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCOR STAT DL 9.5 FR. 34 CC IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. 0684-00-0206-01 04/21/99

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR