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

Catalog Number	SM0005-USA
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Death (1802)
Date of Event	06/25/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
As reported, the patient died following pacemaker placement in a case in which arista-ah was used.The cause of death could not be confirmed.The facility reported that the arista-ah was not causal to the death of the patient.No death certificate, autopsy report, pathology report were provided.No lot number has been provided, therefore, a review of the manufacturing records is not possible.Based on the information provided this appears to have bee an end of life situation for this elderly patient unrelated to the arista ah used to treat the patient.Should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
It was reported that on (b)(6) 2020, patient (male (b)(6) years) underwent a surgery for pacemaker placement.Arista-ah hemostat was used to treat the patient during the implant procedure.In the middle of the night ((b)(6) 2020) after the surgery, the patient's condition suddenly got worse and patient died.The local affiliate was not able to obtain a death certificate.They report that the user facility identified no causal relationship between the patient¿s death and the use of arista-ah.

• Brand Name: ARISTA AH
• 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: 10254927
• Report Number: 1213643-2020-06550
• Device Sequence Number: 18961779
• Product Code: LMG
• UDI-Device Identifier: 00801741044120
• UDI-Public: (01)00801741044120
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P050038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SM0005-USA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/09/2020
• 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: Death