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

Device Problem Insufficient Information (3190)

Patient Problem Blood Loss (2597)

Event Date 12/01/2009

Event Type  Injury  

Manufacturer Narrative

(b)(4).Baxter (b)(4) completed the investigation.As no sample or lot number was provided, sample evaluation and batch review could not be performed.Floseal ifu was reviewed and the instruction of irrigation of excess is provided under floseal matrix placement/application.No trend was identified.Per hayward, the affected product lot is unknown thus the batch record review and retention sample evaluation could not be performed.No further investigation is required.This case will be kept on file for trending purposes.

Manufacturer Narrative

(b)(4).Baxter medical assessment: if a flowable hemostat (floseal) is used to provide hemostasis in partial nephrectomy (nephron-sparing surgery; nss) the collecting system needs to be closed according to urological surgery standards before the hemostat is applied.If this is not the case, floseal can enter the collecting system of the kidney.Closure of the collecting system is a routine surgical measure to prevent urine leaks and other surgery related complications.In addition, all excess floseal (product not reacted with the blood clot) requires meticulous irrigation and aspiration.The reported two cases of reduction of >25% of the glomerular filtration (gfr) may potentially be caused by floseal entering the collecting system.In addition the surgical manipulation of the kidney as well as excess floseal left in situ may induce a local inflammatory reaction causing the reported reduction in glomerular filtration.The reported reduction of the gfr is possibly associated with the use of floseal without appropriate closure of the collecting system and non-irrigation of excess product.A follow-up report will be submitted upon receipt and evaluation of additional information.

Event Description

It was reported from a literature (palacios, diego a.Et.Al., ¿pilot study comparing the two hemostatic agents in patients undergoing partial nephrectomy.¿ bmc research notes 2013, 6:399) that three patients experienced complications after a nephron sparing surgery in which floseal was used.- two (2) patients experienced reduced glomerulus filtration rate (gfr); - one (1) patient experienced a non-urologic complication.This report reflects the patient who experienced reduced glomerulus filtration rate (gfr).This is one of three reports.Abstract: background: recently studies have demonstrated improved outcomes in patients undergoing nephron-sparing surgery (nss) for low stage renal tumors, thus nss is widely accepted as the treatment option for these patients.With nss, there is a risk of renal hemorrhage and thus haemostatic agents may be routinely applied to the cut surface of the kidney.Herein we compare two commercially available haemostatic agents applied intra-operatively to the cut surface of the kidney.Post-operative outcomes (oncologic and non-oncologic) are reported.Methods: the medical records of 23 patients with suspicious renal mass documented on axial imaging and who underwent open nss via a mini-subcostal incision were extensively reviewed.One of two haemostatic agents (floseal, n = 11; arista, n = 12) was intra-operatively applied to the cut surface of the kidney.Chi-square and t- student test was used to compare outcomes between the cohort of 11 patients who had floseal and the 12 patients who had arista.Results: median pre-operative size of renal mass was 4.3 cm (range 1.5-7.0 cm).Final pathology revealed 3 oncocytomas and 20 renal cell carcinoma (17 clear cell, 1 chromophobe and 2 papillary), pt1a = 14 and pt1b = 6.Mean intra-operative blood loss and hospital stay between the flosealw vs.Arista cohorts did not significantly differ (227 ml vs.250 ml, p = 0.68 and 4.4 days vs.4.5 days, p = 0.76, respectively).Intra-operative and post-operative complications were not different between the two cohorts.No recurrences have been documented with a mean follow-up of 18 months.Conclusion: along with meticulous surgical technique, the use of either haemostatic agent (floseal or arista) was not associated with high rate of intra-operative or post-operative haemorrhage.Thus either haemostatic agent may be successfully used during nss.

• 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: 3602508
• MDR Text Key: 11626157
• Report Number: 2032282-2014-00025
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2014
• 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: 02/25/2014
• 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