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

Catalog Number 1501510

Device Problem Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Reaction (2414)

Event Date 02/14/2014

Event Type  Injury  

Event Description

It was reported from a hospital that a patient experienced unintended intestinal adhesion caused ileus after laparoscopic cysts extraction in which floseal was used.It was noted that floseal was rinsed amply and the histological report showed adhesion by foreign body reaction which occurred 10 days after the use of floseal.Sample or batch number is not available.No further information provided.

Manufacturer Narrative

(b)(4).Baxter medical assessment: inflammatory response with foreign body reaction and adhesion formation may occur after use of floseal.In most instances this occurs in cases in which the excess hemostatic matrix (product not reacted with the blood) is not properly irrigated, or in cases in which product is applied too slowly and/or not approximated properly for 2 minutes.This may lead to imbibitions of excess floseal with blood, and even copious irrigation is not able to remove excess product.We cannot exclude that floseal has caused or contributed to the inflammatory reaction with adhesion formation and foreign body reaction.A follow-up report will be submitted upon receipt and evaluation of additional information.

Manufacturer Narrative

(b)(4).Baxter (b)(4) completed the investigation.Sample evaluation could not be performed as no sample was provided.Batch review was performed and all released products met specifications and no nonconformities, failures, rework or deviations were found.No trend was identified.Per vienna, no further investigation is required as the complaint is an expected and foreseeable side effect which is described in the product labeling.This is the first complaint of this nature received for this product lot.The 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 - VIENNA; industriestrasse 67; vienna 1220 ; AU 1220
• Manufacturer (Section G): BAXTER HEALTHCARE - VIENNA; industriestrasse 67; vienna 1220 ; AU 1220
• Manufacturer Contact: kimberly crane ; one baxter way; westlake village, CA 91362 ; 8053723182
• MDR Report Key: 3665592
• MDR Text Key: 17164486
• Report Number: 2032282-2014-00045
• Device Sequence Number: 1
• Product Code: LMF
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P990009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2014
• Device Catalogue Number: 1501510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2014
• 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