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

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Patient 2 of 3: from literature: cenk gurbuz, et.Al."off-clamp laparoscopic partial nephrectomy for a low renal nephromethry scored patients".A-18.Introduction and objectives: because of the impact warm ischemia time may have on renal function, various surgical techniques have been proposed to minimize or eliminate warm ischemia.The objective of this study is to evaluate our initial outcomes of trans or retroperitoneal partial nephrectomy (r/tlpn) performed by off-clamp excision.Methods: between august 2012 and march 2014, 41 consecutive patients underwent off clamp r/tlpn at our institution.After excision of tumor, renorrhaphy plus biologic hemostatics flosealô (baxter healthcare corp., (b)(4)) were performed.Results: majority of the patients (39) were noted to have a low (4¿6) renal nephromethry score (rns) and 2 patients had a moderate (7¿9) rns.No hilar location tumor was noted.The mean tumor size among this cohort was 33.1 (range, 2.0¿6.0) cm, and the mean estimated blood loss was 266 (range, 70¿500)ml.One patient required blood transfusion.Open conversion was needed in 1 patient.The mean hospital stay was 2.9 (range, 2¿5) days.The mean percentage of postoperative estimated glomerular filtration rate change increased by 0.8%.Two patients with grade iii complication by the clavien-dindo classification were treated by endoscopic intervention.Surgical margin was noted positive in 3 patients.Conclusions: our initial experience with off-clamp lpn demonstrates encouraging results of minimal renal function loss and complications in patients with a low rns.Two (2) patients grade iii clavien complications.One (1) patient required conversion to open surgery.(this complaint is regarding one of two patients with grade iii clavien complications.) note: the occurrence date is unknown.

Manufacturer Narrative

(b)(4).Due to the lack of information, this case is currently not assessable and is being conservatively reported.Baxter is currently in the process of following up with the reporter for additional information.A follow-up report will be submitted upon receipt and evaluation of additional information.

Manufacturer Narrative

(b)(4).Multiple attempts were made to contact the author to retrieve additional clinical details.No response was received.Baxter hayward completed the investigation.As neither the lot number nor sample were provided, no batch review or sample evaluation was possible.A review of details of the complaint indicated that no further investigation is required.No trend was identified.If additional information is received at a later time, the information will be evaluated and a follow-up submission will be sent.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: 4116096
• MDR Text Key: 4841146
• Report Number: 2032282-2014-00131
• Device Sequence Number: 1
• Product Code: LMF
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P990009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• 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?: No
• Date Manufacturer Received: 10/23/2014
• 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