MAUDE Adverse Event Report: BAXTER HEALTHCARE - HAYWARD FLOSEAL HEMOSTATIC MATRIX; AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED

Device Problem Insufficient Information (3190)

Patient Problems Abscess (1690); Fever (1858); Hemorrhage/Bleeding (1888); Nausea (1970); Pain (1994); Abnormal Vaginal Discharge (2123); Discomfort (2330); Complaint, Ill-Defined (2331); Ascites (2596)

Event Date 01/01/2009

Event Type  Injury  

Event Description

From literature: charles k.Anderson, md, et al."association between gelatin¿thrombin matrix use and abscesses in women undergoing pelvic surgery." the american college of obstetricians and gynecologists.Published by lippincott williams & wilkins: vol.124, no.3 september 2014: 589-595.Objective: to assess the association between the use of gelatin¿thrombin matrix and the development of pelvic abscess during hysterectomy as well as factors associated with surgeons¿ use of this product.Methods: data for patients undergoing hysterectomy for obstetric¿gynecologic pathology were abstracted from databases at a tertiary hospital between 2009 and 2012.Open and minimally invasive hysterectomies were included and vaginal hysterectomies were excluded.Blood loss, surgery type, comorbidities, abscess formation, and use of gelatin¿thrombin matrix were examined.Abscess was defined as a walled-off fluid collection (documented with computed tomography scan) with fever (greater than 38°c) or leukocytosis (greater than 11,000/microliter).Standard statistical models were used.Results: of the 413 patients identified, 213 (51%) underwent surgery for malignancy.Gelatin¿thrombin matrix was used in 166 patients (40%).The overall rate of abscess was low (3%).In bivariate analyses, blood loss greater than 500 ml (odds ratio [or] 3.9, 95% confidence interval [ci] 1.1¿12.9, p5.021], ascites (or 6.5, 95% ci 1.6¿26.1, p5.023), drain placement (or 4.5, 95% ci 1.3¿15.1, p5.009), and gelatin¿thrombin matrix use (or 7.0, 95% ci 1.5¿32.9, p5.009) were significantly associated with abscess formation.Multivariate logistic regression revealed that only gelatin¿thrombin matrix use predicted the development of pelvic abscess.Conclusion: we found that gelatin¿thrombin matrix use was associated with an increased risk of pelvic abscess.Although these products are important in the setting of bleeding, these data suggest that the liberal use of sealants is not without risk.Patient 3 of 9: it was reported from the literature article that a patient experienced a pelvic abscess including/along with fever, abdominal, pelvic pain in which floseal was used.Post op day: 8, procedure: laparotomy, radical hysterectomy, bso lymphadenectomy, indication for surgery: endometrial cancer, wbc count: 9.8, treatment: iv antibiotics, culture of abscess: n/a, ct findings: 2x2.5-cm ring enhancing fluid collection in the right lower pelvis with adjacent stranding within the location of the excised uterus.Nine (9) patients experienced a pelvic abscess including/along with: patient 1 of 9: purulent vaginal drainage ¿ (b)(4).Patient 2 of 9: abdominal or pelvic pain ¿ (b)(4).Patient 3 of 9: fever, abdominal, pelvic pain ¿ (b)(4).Patient 4 of 9: fever, abdominal or pelvic pain, surgical abdomen - (b)(4).Patient 5 of 9: fever, nausea, abdominal pain - (b)(4).Patient 6 of 9: anorexia, rectal pressure - (b)(4).Patient 7 of 9: abdominal or pelvic pain - (b)(4).Patient 8 of 9: nausea, abdominal pelvic pain - (b)(4).Patient 9 of 9: abdominal pain, discharge - (b)(4).

Manufacturer Narrative

Complaint no: (b)(4).Baxter medical assessment: from the safety profile of floseal use over more than a decade and several publications in abdominal and gynecologic surgery it is well known that incorrect product application in absence of active blood flow (the publication mentions that the gelatin matrix has been often used to prevent bleeding, which is a non-indicated use according to the product labeling), application of copious volumes of the hemostat without irrigation of product excess (material not reacted with the blood clot) may predispose to inflammatory reactions.Inflammation in the presence of a clean contaminated surgical field (according to lake et al, 2013, 99% of the hysterectomies, open and laparoscopic, are considered clean contaminated) may predispose to infection.Giving the limitations of a retrospective case review, and without knowing the relevant product application details for the respective nine cases with confirmed pelvic abscesses, we cannot exclude that floseal and its potential incorrect indication for use, and/or incorrect application, may have caused or contributed to the reported abscess formation.Review of the product labeling shows that all the related risks and correct use recommendations and warnings are adequate and do not require revision.No further clinical investigation is required.A follow-up report will be submitted upon completion of baxter's investigation.

Manufacturer Narrative

(b)(4).Baxter (b)(4) completed the investigation.As no sample was available, sample evaluation could not be performed.Batch record review could not be performed as no lot number was provided.Per baxter (b)(4), no further investigation is required.No trend was identified.This case will be kept on file for trending purposes.

• Brand Name: FLOSEAL HEMOSTATIC MATRIX
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED
• Manufacturer (Section D): BAXTER HEALTHCARE - HAYWARD; 2024 w winton ave; hayward CA 94545
• Manufacturer (Section G): BAXTER HEALTHCARE - HAYWARD; 2024 w winton ave; hayward CA 94545
• Manufacturer Contact: kimberly crane ; one baxter way; westlake village, CA 91362 ; 8053723182
• MDR Report Key: 4129515
• MDR Text Key: 4938182
• Report Number: 2032282-2014-00142
• Device Sequence Number: 1
• Product Code: LMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other