MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION FLIXENE SLIDER GDS; FLIXENE 4-7MMX45CM GWT-GW, W/DBL GDS

Model Number	25138
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.
Event or Problem Description
Report received from the physician stated that the 4mm end of the 4-7 flixene graft is larger then 4mm.
Additional Manufacturer Narrative
The actual product was not returned for evaluation.A full review of the graft lot history records for the devices in question was performed.The records indicate that this lot of grafts passed atriums final lot qualification testing.This inspection requires that the graft lot must pass the following: inspection for tactile or visual defects.No abnormal results were observed.Id testing: graft must be within specified tolerance for inner diameter (.037-.177 inch).All samples were within specification.Wep testing: graft must withstand over 200 mmhg water pressure prior to weeping.The minimum value recorded was 275 mmhg.Srt testing: suture retention force must be above 0.7 lbf.The minimum value recorded was 1 lbf.Rts testing: radial tensile strength must be above 25 lbf.The minimum value recorded was 51 lbf.Lts testing: longitudinal tensile strength must be above 20 lbf.The minimum value recorded was 71 lbf.The instructions for use specify the following: "cut the graft and clear sheath closest to the slider/tunneler rod.Remove and discard the gds.The graft may be cut using sharp surgical scissors or a scalpel.It is strongly recommended that the graft be cut with scissors to provide an even cut.Unless absolutely necessary, it is recommended not to cut the graft until it has been tunneled and is in place, ensuring that the graft will be long enough." based on the details of the event and the successful lot qualification test data, atrium can find no fault with the lot of grafts in question.

• Brand Name: FLIXENE SLIDER GDS
• Common Device Name: FLIXENE 4-7MMX45CM GWT-GW, W/DBL GDS
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; merrimack NH 03054
• MDR Report Key: 6289927
• Report Number: 3011175548-2017-00004
• Device Sequence Number: 16420577
• Product Code: DSY
• UDI-Device Identifier: 00650862251388
• UDI-Public: 00650862251388
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K071923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2017

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: Physician
• Device Expiration Date: 12/19/2019
• Device Model Number: 25138
• Device Catalogue Number: 25138
• Device Lot Number: 410790
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2017
• Supplement Report FDA Received Date: 03/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR