MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. ARISTA AH ABSORBABLE HEMOSTAT; AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED

Catalog Number	SM0002-USA
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Abscess (1690)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported the surgeon applied the arista ah in a clean-contaminated case.The patient developed abscess as a post-op complication and required treatment.It was reported that hemostasis was achieved with use of the arista ah.Following use the excess material was not removed from the site.Our instructions for use (ifu) identifies that excess arista ah should be removed for the site of application by irrigation and aspiration.The possibility of the product interfering with normal function and/or causing compression necrosis of surrounding tissue due to swelling is reduced by removal of excess dry material.The instructions for use (ifu) also warns "arista¿ ah should be used with caution in the presence of infection or in contaminated areas of the body.If signs of infection or abscess develop where arista¿ ah has been applied, re-operation may be necessary in order to allow drainage." based on the reported information we cannot determine the cause of the abscess presenting.However it is possible that residual material left at the site was a factor, and may be attributed to a use issue.A review of the device history records (dhr) confirmed there to be no manufacturing or material issues identified, and the production lot was manufactured to specification.To date this is the only reported complaint for the subject lot of 12365 units released for distribution in july of 2017.Used on patient and discarded.
Event or Problem Description
It was reported that arista ah was used in a laparoscopic hiatal hernia and transoral incisionless fundoplication surgical procedure in which the patient developed an abscess.There was minor bruising to the liver capsule, no active bleeding; therefore, there was no excess blood to be removed prior to the arista ah application.The arista ah was sprayed on the top left lobe of the liver and under it.No other hemostatic agents were used.No direct pressure was applied after application of the arista ah as the surgeon states it was not needed.Excess arista ah was not removed from the site and there were no complicating factors with this procedure.The case was considered clean-contaminated.The arista ah was not sprayed or placed directly into blood vessels.The patient did not have any known defects in their clotting system prior to use of the arista ah.The patient is diabetic.The patient was readmitted 6 days later with anterior and posterior liver abscesses in the area where the arista was used.The patient underwent a laparoscopic drainage of these liver abscesses.

• Brand Name: ARISTA AH ABSORBABLE HEMOSTAT
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8440664
• Report Number: 1213643-2019-01852
• Device Sequence Number: 1664612
• Product Code: LMG
• UDI-Device Identifier: 00801741044106
• UDI-Public: (01)00801741044106
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P050038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2022
• Device Catalogue Number: SM0002-USA
• Device Lot Number: 5829601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2019
• Initial Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR