FLOSEAL
Report
- Report Number
- 2954761-2011-00011
- Event Type
- Injury
- Date Received
- February 9, 2011
- Date of Event
- January 1, 2011
- Report Date
- January 26, 2011
- Manufacturer
- BAXTER HEALTHCARE - HAYWARD
- Product Code
- LMF
- PMA / PMN Number
- P990009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
(B)(4). BAXTER MEDICAL ASSESSMENT: THIS REPORT DESCRIBES A CONTROLLED SERIES OF AN UNKNOWN NUMBER OF CASE REPORTS REFERRING TO THE OCCURRENCE OF INFLAMMATORY REACTIONS ALONG THE APPLICATION SITE OF FLOSEAL AFTER SAPHENOUS VEIN HARVESTING IN CARDIAC PROCEDURES ("MANY PATIENTS"). INFECTIONS CAN BE RULED OUT, SINCE ANTIBIOTIC THERAPY IN SOME OF THE CASES HAS NOT CHANGED THE COURSE OF RECOVERY. A CONTROL GROUP (PATIENTS RECEIVING THE SAME SURGICAL TREATMENT, EXCEPT FLOSEAL; NEGATIVE CONTROL) HAS NOT EXPERIENCED SUCH REACTIONS. DESPITE CLAIMS OF IRRIGATION OF THE PRODUCT, THE INTENDED USE HAS BEEN PROPHYLACTIC (APPLICATION IN THE ABSENCE OF BLEEDING). IN THE WARNINGS SECTIONS OF THE INSTRUCTIONS FOR USE THE FOLLOWING IS STATED: "FLOSEAL MATRIX IS EFFECTIVE ON SURGICAL BLEEDING, FROM OOZING TO SPURTING, AND IS NOT INTENDED TO BE USED AS A PROPHYLACTIC HEMOSTATIC AGENT." WHILE IT IS NOT CLEAR IF THESE REACTIONS HAVE PROLONGED THE HOSPITAL STAY IT APPEARS THAT THEY REQUIRED ADDITIONAL MEDICAL TREATMENT AND ATTENTION. SINCE THIS SINGLE REPORT REFERS TO THE USE "OF FLOSEAL ON THE SAPHENOUS VEIN HARVESTING SITE IN CARDIAC PROCEDURES OF MANY PATIENTS", AND SOME RECEIVED ANTIBIOTIC TREATMENT FOR THE REPORTED COMPLICATION (INFLAMMATORY REACTION WITH EDEMA AND REDNESS) WE HAVE TO VIEW THIS, BASED ON THE EXISTING INFORMATION AS SERIOUS INJURIES. SINCE THE NUMBERS OF OCCURRENCES AND ANTIBIOTIC TREATMENTS ARE UNKNOWN WE CONSERVATIVELY AND PRELIMINARILY CATEGORIZE THE CASE REPORT AS SERIOUS INJURY. THE FACT THAT THE SALES REP IS NOT AWARE OF ANY SERIOUS INJURY, AS STATED IN THE NARRATIVE, IS NOT OF RELEVANCE HERE. FROM THE POST-MARKETING SAFETY PROFILE OF FLOSEAL IT IS KNOWN THAT THE PRESENCE OF EXCESSIVE VOLUMES OF FLOSEAL (NON-IRRIGATION AND/OR IMBIBITION OF EXCESSIVE VOLUMES OF PRODUCT WITH BLOOD) CAN OCCASIONALLY INDUCE INFLAMMATORY REACTIONS, THESE POSTOPERATIVE INFLAMMATORY REACTIONS MAY INCREASES THE INFECTION RISK OF THESE PATIENTS AND MAY ALSO INDUCE SUBSEQUENT HEALING DISORDERS (E.G. FIBROSIS, ENCAPSULATION, FOREIGN BODY REACTIONS). THIS IS WHY THE REACTIONS ARE PRELIMINARILY CATEGORIZED AS SERIOUS INJURIES, AND BASED ON THE EXISTING INFORMATION THEY ARE RELATED TO POTENTIAL ERRORS IN THE INDICATION FOR USE AND/OR THE APPLICATION OF FLOSEAL. THE FACT THAT THESE COMPLICATIONS DID NOT OCCUR IN PATIENTS NOT TREATED WITH FLOSEAL, BUT WITH THE SAME SURGICAL TECHNIQUE (NEGATIVE CONTROL) SUPPORTS OUR CLINICAL JUDGMENT. A FINAL INDIVIDUALIZED MEDICAL ASSESSMENT OF ALL CASES WILL HAVE TO BE PROVIDED UPON RECEIPT OF FURTHER DETAILS ON ALL AFFECTED PATIENTS. (B)(4). NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. BAXTER IS CURRENTLY FOLLOWING-UP WITH THE SURGEON FOR ADDITIONAL CASE DETAILS REGARDING THE MULTIPLE PATIENTS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.
(B)(4). BAXTER FOLLOW-UP MEDICAL ASSESSMENT: ADDITIONAL INFORMATION RECEIVED REFERS TO INFLAMMATORY REACTIONS IN MULTIPLE PATIENTS ON POD 1 OR 2, WHICH ALL SUBSIDED SPONTANEOUSLY WITHOUT ANY ADDITIONAL TREATMENT (NO ANTIBIOTICS) AFTER A FEW DAYS. THE APPARENT CAUSE OF THESE REACTIONS (THAT OCCUR ONLY AT THE HARVESTING SITE OF THE VEIN, NOT AT THE SITE OF CARDIAC APPLICATION OF FLOSEAL) IS ITS POTENTIAL SUPERFICIAL USE IN THE VICINITY OF THE SKIN INCISION. A RESPECTIVE PRECAUTIONARY STATEMENT IS PROVIDED IN THE FLOSEAL INSTRUCTIONS FOR USE. RETRAINING WILL NOT BE REQUIRED, SINCE SURGEON STOPPED USING FLOSEAL IN THIS SPECIFIC SITE AND WILL CONTINUE TO USE THE PRODUCT ONLY ON CARDIAC ANATOMY OR DEEPER LOCATED HARVESTING SITES. SINCE THE INFLAMMATORY REACTIONS DID NOT REQUIRE MEDICAL INTERVENTION, AND OBVIOUSLY DID NOT PROLONGED THE HOSPITAL STAY (AFTER CARDIAC SURGERY) THE COMPLICATION CANNOT BE CLASSIFIED AS A SERIOUS INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THIS CASE. THIS CASE WILL BE KEPT ON RECORD FOR TRENDING PURPOSES.
ADDITIONAL INFORMATION RECEIVED FROM REPORTING SURGEON ON (B)(6)-2011: THE SURGEON USES FLOSEAL IN QUITE A FEW AREAS DURING HER SURGERIES, SUCH AS IN THE MEDIASTINUM AND STERNAL EDGES, ETC. SHE USED TO USE FLOSEAL IN OPEN SAPHENOUS VEIN HARVESTING BUT SHE STOPPED AS SHE NOTICED THAT HER PATIENTS WERE GETTING REDNESS ON DAY 1 OR 2 POST OP. THIS REDNESS RESEMBLED EARLY NECROSIS AND INFECTION; SHE DID NOT PUT ANY PATIENTS ON ANTIBIOTICS. THE SYMPTOMS RESOLVED BY THEMSELVES AFTER 4 OR 5 DAYS. ACCORDING TO THE SURGEON, SHE USES FLOSEAL IN THE FOLLOWING MANNER: SHE APPLIES PRODUCT, APPROXIMATES WITH A MOIST GAUZE FOR 2 MINUTES, AND THEN RINSES THE PRODUCT OFF AND CLOSES THE WOUND. THE SURGEON DID MENTION THAT SHE WAS APPLYING THE PRODUCT TOO CLOSE TO THE SKIN EDGES (SUPERFICIAL ), WHICH COULD BE THE REASON (ACCORDING TO HER) FOR THE INFLAMMATORY REACTION AT THE CLOSURE SITE. SHE HAS SINCE STOPPED USING FLOSEAL IN THIS INDICATION AND HER PATIENTS HAVE NOT HAD THE SAME EXPERIENCE. SHE DID SAY THAT SHE WILL BE USING FLOSEAL IN THE VEIN HARVESTING WHENEVER THE DISSECTION IS DEEPER. ACCORDING TO HER, COMPLICATIONS SUCH AS INFECTION, HEMATOMAS ETC ARE VERY COMMON IN THIS PROCEDURE EVEN IF THE SURGEONS ARE VERY EXPERIENCED AND NOT USING FLOSEAL. ADDITIONAL INFORMATION RECEIVED FROM BAXTER CANADA ON (B)(4)-2011: THE NUMBER OF PATIENTS THAT THE INCIDENTS OCCURRED WITH IS UNKNOWN.
THE CUSTOMER REPORTED THAT THEY WERE USING FLOSEAL ON THE SAPHENOUS VEIN IN CARDIAC SURGERY AS A PREVENTIVE OF BLEEDING IN POST-OP. THEY WERE RINSING AFTER APPLICATION AS WE RECOMMEND. ((B)(6) IN 2010 THE CUSTOMER HAD A DISCUSSION WITH BAXTER THAT FLOSEAL IS NOT A PRODUCT TO BE USED AS A PREVENTIVE PRODUCT FOR BLEEDING, BUT AS A HEMOSTATIC AGENT WHEN THERE IS ACTIVE BLEEDING.) THEY NOTICED IN POST-OP THAT PATIENTS HAD EDEMA AND IT WAS RED ON THE FLOSEAL APPLICATION SITE. THEY STOPPED USING IT AND THE EDEMA AND REDNESS WERE NOT NOTICED ANYMORE ON PATIENTS. THEY DID NOT NOTICE INFECTION ON ANY PATIENT. THE CUSTOMER MENTIONED THAT OTHER SURGEONS ON THE CARDIAC TEAM WERE NOT USING FLOSEAL ON THE SAPHENOUS VEIN AS A "PREVENTIVE" AND THEY NEVER HAD EDEMA AND REDNESS ON THE SAPHENOUS VEIN SITE IN POST-OP. THOSE SURGEONS ARE USING ALL THE SAME OTHER PRODUCTS AS THE OPERATING SURGEON ON SAPHENOUS VEIN. THE ONLY DIFFERENCE BETWEEN THE OPERATING SURGEON AND THE OTHER CARDIAC SURGEONS WAS THE USE OF FLOSEAL. THIS IS WHY THEY THINK IT IS FLOSEAL THAT CAUSES THIS REACTION. PATIENT OUTCOME IS UNKNOWN AT THIS TIME. THE CUSTOMER IS SUPPOSED TO CONTACT BAXTER WITH MORE DETAILS AFTER SHE SPEAKS WITH THE OPERATING SURGEON. ADDITIONAL INFORMATION RECEIVED FROM BAXTER (B)(4) ON (B)(6) 2011: PER THE INFORMATION RECEIVED BY BAXTER, FLOSEAL WAS USED ON THE SAPHENOUS VEIN IN CARDIAC SURGERY ON MANY PATIENTS; THE NUMBER OF PATIENTS IS UNKNOWN AT THIS TIME. ON ALL SUCH PATIENTS THE SURGEON NOTICED A POST-OP EDEMA ON THE FLOSEAL APPLICATION SITE. IT WAS A CONTINUOUS, LOCAL, INFLAMMATORY REACTION, PRESENTED WITH THE RED SKIN. THE SURGEON SUSPECTED AN INFECTION, AND TREATED SOME PATIENTS WITH ANTIBIOTICS. SOME OTHER PATENTS HAD THE SAME REACTION AND WERE NOT TREATED WITH ANTIBIOTICS. THE USE OF ANTIBIOTICS DID NOT MAKE ANY DIFFERENCE. THE SURGEON SUSPECTED THAT IT MAY NOT BE INFECTION AND MAY HAVE BEEN CAUSED BY THE USE OF FLOSEAL. THE ISSUE WAS RESOLVED, ONCE THE USE OF FLOSEAL WAS STOPPED. THE SURGEON "THINKS" THAT FLOSEAL SHOULD BE USED ON DEEP WOUNDS ONLY AND NOT SUPERFICIALLY. BAXTER SALES REP WAS NOT AWARE OF ANY PATIENT INJURY.
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 |