BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL

    MDR report key: 1984175 · Received February 10, 2011

    Report

    Report Number
    2954761-2011-00012
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    November 1, 2010
    Report Date
    February 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    LMF
    PMA / PMN Number
    P990009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE INSTRUCTIONS FOR USE WITH THE REPORTING SURGEON (WITH SPECIAL FOCUS ON THE NEED FOR IRRIGATION OF EXCESS AFTER 2 MINUTES OF APPROXIMATION, WHEN HEMOSTASIS HAS BEEN ACHIEVED) HAS BEEN COMPLETED. THEREFORE, NO FURTHER INVESTIGATION IS REQUIRED. THIS CASE WILL BE KEPT ON RECORD FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: THE CASE DESCRIBES A WELL KNOWN OCCURRENCE IN CASE THE EXCESS FLOSEAL (MATERIAL NOT REACTED WITH THE BLOOD CLOT) IS NOT IRRIGATED, OR THE APPLICATION AND/OR APPROXIMATION OF THE PRODUCT DURING APPLICATION IS NOT FAST ENOUGH. UNDER THESE CIRCUMSTANCES SEVERAL PUBLICATIONS AND REPORTS FROM THE POST MARKETING FIELD SURVEILLANCE HAVE SHOWN THAT ISOLATED INFLAMMATORY REACTIONS OR EVEN ADHESION FORMATION MAY OCCUR. THE PLAUSIBLE ROOT CAUSE OF THESE COMPLICATIONS IS THE LACK OR IRRIGATION OF EXCESS PRODUCT AND/OR SUBOPTIMAL APPLICATION TECHNIQUE. THE ADVERSE EVENT IS POSSIBLY RELATED TO THE INCORRECT APPLICATION (USER ERROR) OF FLOSEAL. THE REPORT DOES REVEAL THAT IRRIGATION OF FLOSEAL IS NOT PERFORMED AFTER ACHIEVED HEMOSTASIS, BUT A FEW DAYS LATER, WHEN THE THORAX IS BEING CLOSED IN THESE STAGED PEDIATRIC CARDIAC PROCEDURES. THIS IS NOT IN LINE WITH THE RECOMMENDATIONS OF THE INSTRUCTIONS FOR USE. WE RECOMMEND A DOCUMENTED REVIEW OF THE INSTRUCTIONS FOR USE WITH THE REPORTING SURGEON, WITH SPECIAL FOCUS ON THE NEED FOR IRRIGATION OF EXCESS AFTER 2 MINUTES OF APPROXIMATION, WHEN HEMOSTASIS HAS BEEN ACHIEVED. IRRIGATION OF FLOSEAL A FEW DAYS LATER IS AGAINST THE GUIDANCE OF THE INSTRUCTIONS FOR USE AND MAY CONTINUE TO CAUSE AUGMENTATIONS OF THE SURGERY-RELATED INFLAMMATORY REACTION IN THIS PATIENT POPULATION. (B)(4). NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. BAXTER WILL BE COORDINATING A REVIEW OF THE INSTRUCTIONS FOR USE WITH EMPHASIS ON PROPER APPLICATION TECHNIQUE WITH THE SURGEON. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION AND/OR COMPLETION OF THE IFU REVIEW.

    Description of Event or Problem · 1

    THE REPORTER NOTICED A FLOSEAL ISSUE IN A PEDIATRIC CARDIAC PATIENT AROUND (B)(6). THIS PATIENT WAS 1ST OPERATED ON IN (B)(6) (EXACT DATE NOT AVAILABLE). THIS OPERATION WAS REQUIRED DURING THE NORMAL TREATMENT OF CARDIAC ISSUES FOR THIS PATIENT. THE OPERATION IN (B)(6) WAS NOT THE 1ST OPERATION FOR THIS PATIENT; THE OPERATION IN (B)(6) WAS AT LEAST THE 3RD CARDIAC PROCEDURE PERFORMED ON THE PATIENT. DURING THE OPERATION IN (B)(6), FLOSEAL WAS USED TO STOP THE BLEEDING AROUND A VENOUS ANASTOMOSIS TO THE HEART AND NOT IRRIGATED AWAY (BATCH AND UNIQUE PATIENT ID NOT PROVIDED). DURING THE OPERATION IN (B)(6), FLOSEAL WAS CLEARLY VISIBLE AND DID NOT APPEAR TO HAVE BEEN ABSORBED AT ALL. IT IS ESTIMATED THAT THIS WAS 6 WEEKS AFTER FLOSEAL USE AND AS THE LABEL SUGGESTS, FLOSEAL MAY NOT BE ABSORBED AT THIS TIME; HOWEVER, THE SURGEON WAS CONCERNED THAT FLOSEAL DID NOT EVEN APPEAR TO BE ABSORBING. REGARDLESS OF ABSORPTION, THE CONSULTANT WAS MAINLY CONCERNED WITH THE LEVEL OF INFLAMMATION AT AND ABOVE THE SITE OF FLOSEAL APPLICATION. THIS INFLAMMATION MANIFESTED ITSELF AS ADHESION FORMATION. ALTHOUGH ADHESIONS ARE EXPECTED AS PART OF THESE OPERATIONS AND ESPECIALLY AT 3RD STERNAL OPENING, THE CONSULTANT STILL FELT THAT THEY WERE MORE AGGRESSIVE THAN EXPECTED. HE DID SAY HOWEVER, THAT THERE COULD BE OTHER CONTRIBUTING FACTORS TO THE DEVELOPMENT OF ADHESIONS SUCH AS PREVIOUS ADHESION DISSECTION AND ALSO A SMALL AMOUNT OF BLEEDING AROUND THE AREA. AS A RESULT OF THIS THE SURGEONS ARE MORE CAREFUL ABOUT IRRIGATING FLOSEAL AWAY. THEY DO NOT IRRIGATE AT THE TIME OF APPLICATION, BUT RATHER AT STERNAL CLOSURE (WHICH IN PEDIATRIC PATIENTS TENDS TO BE DELAYED FOR A FEW DAYS AFTER THE OPERATION TO ALLOW THE HEART TO SETTLE).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1