BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL HEMOSTATIC MATRIX

    MDR report key: 3040932 · Received April 8, 2013

    Report

    Report Number
    2032282-2013-00035
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    LMF
    PMA / PMN Number
    P990009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT SUMMARY: BRAIN EDEMA MAY OCCUR ONLY IN CONJUNCTION WITH THE INCORRECT USE OF FLOSEAL. THE COMBINATION OF TWO USER ERRORS: A TOO SLOW APPLICATION AND/OR APPROXIMATION OF FLOSEAL IN CONJUNCTION WITH NO OR INSUFFICIENT IRRIGATION OF THE EXCESS PRODUCT, OR THE BLOOD IMPREGNATION OF THE HEMOSTATIC MATRIX WITH BLOOD MAY LEAD (DUE TO THE PRESENCE OF THE HEMOSIDERIN IN THE BLOOD) TO VASOSPASM THAT INDUCES OR MAY AUGMENT BRAIN EDEMA. WHILE THE NARRATIVE CLAIMS APPLICATION OF PRODUCT ACCORDING TO THE IFU, AN EDEMA RELATED TO FLOSEAL CAN ONLY OCCUR UNDER THE CIRCUMSTANCES OUTLINED ABOVE. ALSO OTHER CAUSES (TUMOR SURGERY, INTRAOPERATIVE HYPOTENSION, ETC.) MAY RESULT IN AN EXACERBATED BRAIN EDEMA. A FINAL CAUSALITY RELATIONSHIP WILL BE DETERMINED UPON RECEIVING ADDITIONAL CASE INFORMATION (NOT IMPACTING PATIENT PRIVACY). SO FAR WE CANNOT EXCLUDE THAT FLOSEAL (AND POTENTIAL USER ERRORS) MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED BRAIN EDEMA. ------------ BAXTER WILL FOLLOW-UP WITH THE REPORTER FOR ADDITIONAL INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE REVIEW AND EVALUATION OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2013 FROM THE SITE: INDICATION FOR SURGERY? STOP BLEEDING. SURGICAL APPROACH AND DURATION OF SURGERY? BURR HOLE ENDOSCOPY. INTRAOPERATIVE BLOOD LOSS (VOLUME)? 100CC. INDICATION FOR USE OF FLOSEAL? YES. HAS FLOSEAL BEEN APPLIED IN THE PRESENCE OF ACTIVE BLEEDING? YES. HAS THE EXCESS PRODUCT BEEN METICULOUSLY IRRIGATED? YES. WHAT WHERE THE FINDINGS OF THE POSTOPERATIVE NEUROIMAGING? ONE CASE IS NO BLOOD. ONE CASE STILL HAD BLOOD IN BRAIN. BAXTER FINAL MEDICAL ASSESSMENT: FLOSEAL HAS BEEN USED IN AN ENDOSCOPIC EVACUATION OF AN INTRACEREBRAL HEMATOMA. IT APPEARS THAT SURGEON HAS USED THE HEMOSTAT AS RECOMMENDED; TWO PATIENTS REPORTED ((B)(6)): ONE HAD STILL SOME RESIDUAL HEMATOMA, THE OTHER (NOT DETERMINED WHICH ONE) HAD NO HEMATOMA ON THE POSTOPERATIVE NEUROIMAGING. WHILE INTRACEREBRAL BLEEDING, SURGERY, AND RESIDUAL HEMATOMA MAY CAUSE BRAIN EDEMA, BASED ON THE EXISTING CLINICAL INFORMATION WE CANNOT EXCLUDE THAT FLOSEAL HAS BEEN APPLIED INCORRECTLY AND BY THAT CONTRIBUTED TO THE PERSISTENT BRAIN EDEMA. ANOTHER POTENTIAL EXPLANATION FOR THE REPORTED BRAIN EDEMA MAY BE INCREASED ENDOTOXIN LEVELS. INVESTIGATION OF ENDOTOXIN LEVELS OF THE RESPECTIVE TWO LOTS IS RECOMMENDED. WE CANNOT EXCLUDE THAT FLOSEAL HAS CAUSED OR CONTRIBUTED TO THE REPORTED COMPLICATION. BAXTER (B)(4) COMPLETED THE INVESTIGATION. NO SAMPLE WAS AVAILABLE THEREFORE SAMPLE EVALUATION COULD NOT BE PERFORMED. BATCH REVIEW WAS PERFORMED FOR THE REPORTED LOT AND NO ISSUES WERE IDENTIFIED AND THE BATCH RECORD SHOWED NO NONCONFORMITIES IN THE PRIOR AND SUBSEQUENT BATCHES. PER (B)(4), NO ADDITIONAL INVESTIGATION IS REQUIRED AT THIS TIME. BAXTER (B)(4) SCHEDULED A RE-TRAINING SESSION WITH THE REPORTER REGARDING THE APPROPRIATE USE OF THE PRODUCT IN (B)(4). THIS IS THE FIRST COMPLAINT OF THIS NATURE RECEIVED FOR THIS PRODUCT LOT. THE CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    PATIENT 1 OF 2: TWO NEUROSURGEONS FROM THE SAME HOSPITAL REPORTED TO BAXTER (B)(4) THAT FLOSEAL WAS USED ON 2 PATIENTS. THE DOCTORS INFORMED THAT THEY USED FLOSEAL ACCORDING TO THE IFU (INSTRUCTIONS-FOR USE), HOWEVER, THE PATIENTS DEVELOPED SERIOUS EDEMA FOR A LONG PERIOD OF TIME. THE PATIENTS WERE HOSPITALIZED BEFORE THE EVENT, BUT HOSPITALIZATION WAS PROLONGED DUE TO THE EVENT. THE PATIENTS RECEIVED A "DE-HYDRATE" THERAPY FOR TWO WEEKS (NORMALLY PATIENTS ONLY REQUIRE AROUND 1 WEEK "DE-HYDRATE" THERAPY), ICP. THE PATIENTS THEN RECOVERED AFTER TREATMENT. DUE TO PRIVACY THE DOCTOR REJECTED TO FURTHER PROVIDE PATIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142915 FLOSEAL HEMOSTATIC MATRIX AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED LMF BAXTER HEALTHCARE - HAYWARD HA120348

    Patients

    Seq Age Sex Outcome Treatment
    1 Other