MAUDE Adverse Event Report: ATRIUM MEDICAL ADVANTA SLIDER GDS; PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER

Model Number	22114
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
During the implant of an arterio-venous graft, the clinician noticed some foreign substance on the graft.
Additional Manufacturer Narrative
Analysis: the device was not returned.The details of the complaint indicate that the graft had foreign matter on the surface.Based on the image provided it is difficult to determine the presence of foreign matter.Conclusion: based on the review of the device history records, the image provided and complaint details atrium medical corporation cannot determine the actual presence of the foreign matter or determine if what was seen in the field came from the manufacturer or after the product was opened in the field.Atrium medical corporation 100% inspects every graft for particulate or foreign matter prior to packaging of the graft to ensure the product is clean.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The product was returned from the field.The returned graft was evaluated to determine what the particulate was.Upon inspection no particulate was found on the graft after reviewing the surface of the device under 10x magnification.
Event or Problem Description
N/a.

• Brand Name: ADVANTA SLIDER GDS
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8127370
• Report Number: 3011175548-2018-01425
• Device Sequence Number: 11166924
• Product Code: DYF
• UDI-Device Identifier: 00650862221145
• UDI-Public: 00650862221145
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K992441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 22114
• Device Catalogue Number: 22114
• Device Lot Number: 427108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 01/15/2019; 01/21/2019
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 01/16/2019; 01/22/2019
• 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