BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL HEMOSTATIC MATRIX

    MDR report key: 2093477 · Received May 18, 2011

    Report

    Report Number
    2954761-2011-00031
    Event Type
    Injury
    Date Received
    May 18, 2011
    Report Date
    May 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    LMF
    PMA / PMN Number
    P990009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: THE PROVIDED CLINICAL INFORMATION IS NOT SUFFICIENT TO PROVIDE A CAUSAL RELATIONSHIP WITH ANY OF THE PRODUCTS USED. APPARENTLY THE SURGEON HAS USED BOT FLOSEAL AND TISSEEL DURING SURGERY. FURTHER INVESTIGATION NEEDS TO CLARIFY THE FOLLOWING: DIAGNOSIS FOR SURGERY, TYPE OF SURGERY, AND INDICATION FOR USING FLOSEAL AND TISSEEL INTRAOPERATIVELY. PREEXISTING PATHOLOGY, PREVIOUS SURGERIES AND RISK FACTORS FOR ADHESION FORMATION. APPLICATION DETAILS FOR FLOSEAL (VOLUME OF FLOSEAL APPLIED; APPLICATION IN THE PRESENCE OF ACTIVE BLEEDING; HAS THE EXCESS PRODUCT BEEN IRRIGATED; HAS THE PRODUCT BEEN APPLIED FOR PROPHYLACTIC PURPOSES, I.E. TO PREVENT ADHESIONS OR POSTOPERATIVE BLEEDING) APPLICATION DETAILS FOR TISSEEL (INDICATION, VOLUME USED, TYPE OF APPLICATION DEVICE USED) WHEN DID BOWEL OBSTRUCTION OCCUR (DAYS AFTER INITIAL SURGERY IN WHICH FLOSEAL AND TISSEEL HAVE BEEN USED) AND WHAT CAUSED THE OCCLUSION. DID OCCLUSION OCCUR IN THE SAME ANATOMIC AREA IN WHICH FLOSEAL AND/OR TISSEEL HAVE BEEN APPLIED? TREATMENT OF THE REPORTED COMPLICATION AND OUTCOME. (B)(4). DUE TO THE LACK OF INFORMATION, THIS CASE IS BEING CONSERVATIVELY REPORTED. BAXTER IS CURRENTLY IN THE PROCESS OF FOLLOWING UP WITH THE SURGEON FOR ADDITIONAL INFORMATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER FOLLOW-UP MEDICAL ASSESSMENT: WHILE THE CLINICAL QUESTIONS OF THE MEDICAL ASSESSOR HAVE NOT BEEN ENTIRELY ANSWERED, IT APPEARS PLAUSIBLE THAT FLOSEAL HAS NOT BEEN IRRIGATED AFTER APPLICATION AND IT IS STILL UNCLEAR WHETHER FLOSEAL HAS BEEN APPLIED IN THE PRESENCE OR ABSENCE OF ACTIVE BLEEDING. THE EXTREMELY VAGUE CLINICAL DATA PROVIDED DOES NOT ALLOW A CLEAR DETERMINATION OF A CAUSAL RELATIONSHIP. SINCE PRESENCE OF EXCESS PRODUCT MAY POTENTIALLY CONTRIBUTE IN RARE CASES TO SUCH ADVERSE EVENTS, WE CANNOT EXCLUDE THE CONTRIBUTION OF FLOSEAL TO THE REPORTED BOWEL OBSTRUCTION. REPORTING SURGEON REQUIRES RETRAINING REGARDING CORRECT APPLICATION OF FLOSEAL AS PER THE RECOMMENDATIONS OF THE IFU (REVIEW THE NEED OF APPLICATION IN THE PRESENCE OF ACTIVE BLEEDING, THE NEED TO WORK FAST, APPROXIMATE THE APPLIED PRODUCT AND IRRIGATE THE EXCESS AFTER ACHIEVED HEMOSTASIS). (B)(4). AN ADDITIONAL ATTEMPT WILL BE MADE TO OBTAIN THE REMAINING INFORMATION REQUESTED FROM THE MEDICAL DIRECTOR. THIS IS IN ADDITION TO THE ATTEMPT TO ADVISE THE SURGEON OF APPROPRIATE APPLICATION TECHNIQUE. A FOLLOW-UP SUBMISSION WILL BE SUBMITTED APPROPRIATELY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE APPROPRIATE APPLICATION TECHNIQUE FOR FLOSEAL WAS REVIEWED BY BAXTER WITH THE REPORTING SURGEON, INCLUDING APPLICATION ONLY TO ACTIVELY BLEEDING SITES, SPEED OF APPLICATION AND APPROXIMATION, AS WELL AS THE IMPORTANCE IF REMOVAL ALL EXCESS MATRIX FROM THE WOUND. ALL INFORMATION AVAILABLE HAS BEEN PROVIDED. THIS CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM OPERATING SURGEON: ON THE FLOSEAL EVENT OF SMALL BOWEL OBSTRUCTION, THIS WAS A CASE OF HYSTERECTOMY PERFORMED ROBOTICALLY, DUE THE EXISTENCE OF A LARGE PELVIC MASS. THE PATIENT DEVELOPED SMALL BOWEL OBSTRUCTION POSTOPERATIVELY, WHICH WAS THEN REVIEWED LAPAROSCOPICALLY. DR. (B)(6) DID NOT RECALL THE PATIENT'S AGE OR WHEN THE LAPAROSCOPIC REVISION WAS PERFORMED, BUT HE SAID "A FEW DAYS AFTER," DURING WHICH HE REPORTED FINDING "CLUMP OF WHITE, SOLID, CRYSTALLIZED FLOSEAL ATTACHED TO THE BOWEL." HE WAS UNAWARE OF FURTHER COMPLICATIONS FOLLOWING THE SECOND INTERVENTION. HE ALSO MENTIONED THAT THIS CASE WAS PRESENTED AT (B)(4) IN 2010 BY DR. (B)(6).

    Description of Event or Problem · 1

    THE SURGEON REPORTED TO THE SALES REP THAT A PATIENT EXPERIENCED BOWEL OBSTRUCTION AS A RESULT OF USING BOTH FLOSEAL AND TISSEEL. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other