BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERCOR STAT DL 9.5 FR. 40CC IAB

    MDR report key: 80187 · Received March 28, 1997

    Report

    Report Number
    2248146-1997-00227
    Event Type
    Death
    Date Received
    March 28, 1997
    Date of Event
    February 20, 1997
    Report Date
    February 28, 1997
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: A PARTIAL IAB, CONSISTING OF THE BALLOON MEMBRANE AND APPROX. 3" OF ATTACHED CATHETER MEMBRANE, WAS RETURNED FOR EVALUATION WITH A LARGE DRIED BLOOD CLOT (MEASURING 1" X .5") NOTED WITHIN THE MEMBRANE (AT A LOCATION OF 5" PROXIMAL TO THE BALLOON TIP). THE MEMBRANE INTERIOR WAS ALSO FILLED WITH A LARGE QUANTITY OF DRIED BLOOD. THE MEMBRANE AT THE PROXIMAL TAPER WAS OBSERVED TO BE STRETCHED. A SMOOTH-EDGED SLICE WAS NOTED IN THE MEMBRANE AT A LOCATION OF 5.5" DISTAL TO THE CATHETER/MEMBRANE JUNCTION. VISUAL EXAMINATION REVEALED FORCEPS-LIKE MARKINGS ON THE MEMBRANE SURFACE LOCATED APPROX. 6.5" DISTAL TO THE CATHETER/MEMBRANE JUNCTION. UNDERWATER LEAK TESTING REVEALED THE PRIMARY LEAK SITE IN THE MEMBRANE WHICH CAUSED BLOOD TO ENTER THE DEVICE. UNDER MICROSCOPY, A RAGGED-EDGED PENETRATION WAS SEEN WITHIN A WHITISH PATCH. THE PATCH, WHEN STAINED, EXHIBITED THE TYPICAL APPEARANCE OF AN ABRASION MARK. IN ADDITION, ABRASION MARKS WERE NOTED ON THE MEMBRANE SURFACE. THE RAGGED-EDGED PENETRATION LOCATED WITHIN AN ABRASION MARK IS TYPICAL OF THAT PRODUCED BY CALCIFIED PLAQUE DURING IABP. PLAQUE ABRASION AND THE ULTIMATE PENETRATION OF THE INTRA-AORTIC BALLOON IS NOT ENTIRELY UNCOMMON AND HAS BEEN RPT'D IN THE LITERATURE ON VARIOUS OCCASIONS. UNFORTUNATELY, ALL INTRA-AORTIC BALLOONS ARE THE POSSIBLE SUBJECTS OF PLAQUE ABRASION, THE TIME BEING DETERMINED BY SUCH VARIABLES AS THE DEGREE OF CALCIFICATION OF THE PLAQUE, ITS LOCATION WITHIN THE AORTA, AND ON THE SIZE AND SHAPE OF THE AORTA, AS WELL AS THE BALLOON'S POSITION IN RELATION TO THAT PLAQUE. THE PHYSICAL EVIDENCE (LARGE BLOOD CLOT WITHIN THE IAB MEMBRANE/SMOOTH-EDGED SLICE/FORCEPS-LIKE MARKINGS) AND RPT'D PROBLEM IS CONSISTENT WITH THAT OF AN IAB WHICH BECAME ENTRAPPED AND NEEDED TO BE SURGICALLY REMOVED FROM THE PT. THE SMOOTH-EDGED SLICE IN THE MEMBRANE MOST LIKELY RESULTED DURING BALLOON REMOVAL. ALTHOUGH THE PT CONSEQUENCES OF BALLOON PENETRATION REMAIN OVERWHELMINGLY BENIGN, GENERALLY NECESSITATING ONLY THE REMOVAL OF THE BALLOON AND ITS POSSIBLE REPLACEMENT, THE MEDICAL COMMUNITY IS BECOMING INCREASINGLY AWARE OF THE "ENTRAPPED BALLOON" PHENOMENON. SINCE IT IS POSSIBLE FOR A SMALL LEAK TO BE SELF LIMITING, THE BLOOD WITHIN THE BALLOON MAY DEHYDRATE UNDER THE CONTINUED ACTION OF HELIUM TO FORM A CLOT DURING INTRA-AORTIC BALLOON PUMPING, BEFORE ENOUGH BLOOD ENTERS TO BECOME VISIBLE IN THE CATHETER. THIS CLOT MAY CAUSE THE BALLOON TO BECOME TOO LARGE FOR PERCUTANEOUS REMOVAL OR TO BECOME "ENTRAPPED" IN THE ARTERY. BALLOON ENTRAPMENT NECESSITATING SURGICAL REMOVAL HAS BEEN RPT'D IN LITERATURE AND HAS BEEN EXPERIENCED BY USERS OF INTRA-AORTIC BALLOONS. CO THEREFORE URGE THE USER, AS CO HAS IN THE INSTRUCTIONS, TO DISCONTINUE PUMPING AND CONSIDER THE REMOVAL OF THE BALLOON FROM THE PT AT ONCE IF A BALLOON LEAK IS SUSPECTED. IF, FOR ANY REASON, UNDUE RESISTANCE IS MET DURING REMOVAL OF THE BALLOON, THE USER IS ADVISED TO CALL FOR A VASCULAR CONSULTATION, AS WAS DONE IN THIS CASE.

    Description of Event or Problem · 1

    THE "LEAK IN IAB" ALARM SOUNDED FROM THE PUMP. WHEN DOCTOR TRIED TO REMOVE THE IAB, HE WAS UNABLE TO, THE IAB WAS ENTRAPPED. AS A RESULT OF EVENT, PT WENT TO SURGERY. PT'S LEFT GROIN WAS OPENED AND AN ARTERIOTOMY AND THROMBECTOMY OF THE RIGHT ILIAC ARTERY WAS PERFORMED DUE TO BALLOON BEING FILLED WITH COAGULATED BLOOD. PT HAD EXCESSIVE BLEEDING AND WENT ON TO EXPIRE ON 2/20/97. FACILITY IS ATTRIBUTING EVENT TO PT'S DEATH. EVENT COMPLICATIONS: IAB ENTRAPPED/SURGICALLY REMOVED/BLEEDING/DEATH - RPT'S 2/28/97. PT'S CURRENT STATUS: EXPIRED - RPT'D 2/28/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCOR STAT DL 9.5 FR. 40CC IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION 0784-00-0126 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| R