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

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 05/01/2014

Event Type  Injury  

Event Description

Study title: (b)(4).This is an investigator initiated study (iis) case supported by baxter.Between (b)(6) 2009 and (b)(6) 2011,103 total shoulder replacements were performed by a single surgeon with the use of the hemostatic agent, floseal.All patients were initially evaluated with a history, active range of motion (rom), and radiographic measurements including antero-posterior (ap) and axillary (ax) radiographs.One patient developed a post-operative infection and required arthroscopic débridement, distal clavicle resection, and suprascapular nerve decompression.No sample available.

Event Description

(b)(4).Baxter medical science liaison spoke with dr.(b)(6) research coordinator ((b)(6)) and she said that dr.(b)(6) stated that the infection that she ((b)(6)had written the first draft that was provided to baxter) had included in the draft manuscript was not a procedure-related infection.Apparently when they were in surgery and got down to the surgical site they identified what looked to be an infection, they cultured it, and post operatively the culture came back positive.This identification of a possible infection was made prior to floseal having been used.Therefore, he said that this was unrelated to floseal use, as he suspected this infection to be present prior to use, as he identified it during surgery.

Manufacturer Narrative

(b)(4).Baxter medical assessment: postoperative infection is a rare, but yet expected complication after surgical procedures.Given the limited clinical information (mention of adverse event in a clinical publication), and the inability for further clinical investigation, we cannot exclude that floseal has contributed to the reported postoperative complication.A follow-up report will be submitted upon receipt and completion of the manufacturer's investigation.

Manufacturer Narrative

(b)(4).Baxter hayward completed the investigation.Sample evaluation and batch review could not be performed as no sample or lot number was provided.Floseal¿s instructions for use (ifu) was reviewed and it was found to be adequate and sufficient.No trend was identified.Per hayward, no further investigation is required.This case will be kept on file for trending purposes.

Manufacturer Narrative

(b)(4).Additional case information was received on (b)(4) 2014 and the case was re-assessed by baxter's medical director.Baxter final medical assessment: based on the additional clinical information received the reported infection has been detected during the surgical procedure and before the application of floseal.Therefore, the reported postoperative infection is not related to the use of floseal.As the case was determined to be not related to the use of floseal, no further action is necessary.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: 3801016
• MDR Text Key: 4525117
• Report Number: 2032282-2014-00069
• 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: Study,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2014
• 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