BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL HEMOSTATIC MATRIX HUMAN THROMBIN

    MDR report key: 1813405 · Received August 24, 2010

    Report

    Report Number
    2954761-2010-00034
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    July 20, 2010
    Report Date
    August 16, 2010
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    LMF
    PMA / PMN Number
    P990009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: FROM THE FOLLOW UP INFORMATION THAT DETAILS THE PROCEDURE AND APPLICATION, NO USER ERROR IS OBVIOUS. ALSO REESTABLISHMENT OF RENAL VASCULAR SUPPLY IS CONFIRMED. WHILE NO ANGIOGRAPHIC CONFIRMATION OF A VASCULAR OCCLUSION (THROMBOSIS) IS AVAILABLE TO CONFIRM A THROMBOSIS, ONE CANNOT EXCLUDE THE CONTRIBUTION OF FLOSEAL AND/OR ITS APPLICATION TO THE DESCRIBED EVENT. FURTHER INVESTIGATION IS NOT REQUIRED, RETRAINING NOT NECESSARY. (B)(4).

    Description of Event or Problem · 1

    THE DOCTOR PERFORMED A 2 STAGE BILATERAL PARTIAL NEPHRECTOMY AND USED FLOSEAL IN BOTH CASES. THE PATIENT (AGE: (B)(6)) IS NOW ON DIALYSIS WITH A 20 ML URINE OUTPUT PER DAY. THE DOCTOR IS QUESTIONING IF FLOSEAL COULD HAVE CAUSED A RENAL OR ARTERIAL THROMBOSIS, AS IT IS THE ONLY THING HE HAS DONE DIFFERENTLY AFTER 13 YEARS OF PERFORMING THIS OPERATION. ADDITIONAL INFORMATION RECEIVED FROM COMMUNICATION WITH DOCTOR ON (B)(4) 2010: THE FIRST PROCEDURE WAS AN OPEN LT. PARTIAL NEPHRECTOMY FOR RENAL CELL CARCINOMA RESECTION. THE EXCISION EXTENDED INTO THE COLLECTING SYSTEM OF THE LEFT KIDNEY AND A DOUBLE J URETERAL STENT WAS PLACED TO PROTECT THE URETER FROM BLOCKING. THE DOCTOR TEMPORARILY CLAMPED THE BLOOD SUPPLY TO THE KIDNEY USING HIS ROUTINE TECHNIQUE, WARM ISCHEMIC TIME WAS BETWEEN 20 - 25 MINUTES. HE RE-ESTABLISHED BLOOD FLOW TO THE KIDNEY AFTER TUMOR EXCISION AND SUTURE CLOSURE OF THE COLLECTING SYSTEM, THEN HELD PRESSURE AGAINST THE BLEEDING EXCISION SITE FOR APPROXIMATELY 5 MINUTES. UPON REMOVAL OF THE COMPRESS, THE EXCISION SITE CONTINUED TO BLEED. THE DOCTOR THEN APPLIED FLOSEAL TO THE VISIBLY BLEEDING EXCISION SITE, APPLIED A SURGICAL BOLSTER. BLOOD SUPPLY TO THIS KIDNEY APPEARED NORMAL INTRA-OPERATIVELY UPON RE-ESTABLISHMENT OF BLOOD FLOW. THE PATIENT HAD AN UNEVENTFUL RECOVERY FROM THIS SURGERY AND 3.5 WEEKS LATER, RETURNED TO HOSPITAL FOR REMOVAL OF A RENAL CELL CARCINOMA FROM HER RIGHT KIDNEY. THIS WAS PERFORMED AGAIN BY THE SAME DOCTOR USING THE EXACT SAME TECHNIQUE WITH A WARM ISCHEMIC TIME OF APPROXIMATELY 15 MINUTES. AGAIN INTRA-OPERATIVE RE-ESTABLISHMENT OF BLOOD FLOW APPEARED NORMAL, WITH THE KIDNEY "PINKING UP NICELY." TWO HOURS POST OPERATIVELY, THE DOCTOR RECEIVED A CALL FROM HIS RESIDENT STATING THAT THE PATIENT HAD NO URINE OUTPUT. PATIENT WAS TREATED WITH DIURETICS AND INCREASED IV FLUIDS WITH NO EFFECT. THE PATIENT HAS SINCE BEEN ON DIALYSIS. NUCLEAR MEDICINE TESTING CLEARLY DEMONSTRATES A LACK OF BLOOD FLOW TO BOTH KIDNEYS, HOWEVER THERE HAS BEEN NO DETERMINATION ON THE CAUSE OF THE LACK OF BLOOD FLOW. THE DOCTOR UNDERSTANDS THAT HIS APPLICATION OF FLOSEAL TO AN ACTIVELY BLEEDING SITE FOLLOWS THE GUIDANCE IN THE IFU AND HE CONFIRMED THAT HE DID NOT COMPRESS THE FLOSEAL MATRIX INTO THE EXCISION SITE. HE IS UNDER THE IMPRESSION THAT A RETROGRADE COAGULATION CAUSED BY FLOSEAL IS UNLIKELY, HOWEVER HE WONDERS IF THIS COULD BE SOME TYPE OF REACTION TO ONE OF THE COMPONENTS OF FLOSEAL. HE DID NOT CHECK THE FUNCTION OF THE LEFT KIDNEY PRIOR TO OPERATING ON THE RIGHT SINCE URINE OUTPUT APPEARED NORMAL. HE THEREFORE HAS NO WAY OF KNOWING IF THE FUNCTION OF THE LEFT KIDNEY WAS IMPAIRED FOLLOWING THE FIRST SURGERY AND WASN'T APPARENT UNTIL RIGHT KIDNEY WAS OPERATED ON 3.5 WEEKS LATER. THE PUBLISHED DATA ON THE USE OF FLOSEAL IN PARTIAL NEPHRECTOMIES AS WELL AS THE PRECLINICAL DATA ON THE BEHAVIOR OF FLOSEAL IN THE PRESENCE OF URINE PUBLISHED BY CLAYMAN ETAL FROM UNIVERSITY OF CALIFORNIA IRVINE WAS ALSO DISCUSSED. THE DOCTOR IS FAMILIAR WITH THESE PUBLICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR