MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION FLIXENE SLIDER GDS; 6MMX50CM FLIXENE GRAFT, GW, W/GDS

Model Number	25058
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	01/09/2017
Type of Reportable Event	Serious Injury
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 stated the flixene graft was placed for dialysis in a patient but the anastomosis was not done correctly.The graft was cut too short and kinked.Patient was given a catheter for dialysis.
Additional Manufacturer Narrative
The complaint sample was not returned for evaluation.The investigation revealed that the surgeon had inadvertently cut the graft too short during the procedure, therefore the anastomosis was not done correctly.The instructions for use describe the importance of graft length in the precautions section."grafts must be fully extended prior to sizing length for implantation." summary/conclusion: the graft was not retuned for evaluation.The device history records for this lot of grafts was reviewed and all of the test data met specifications.Based upon the additional event information provided by the facility it was concluded that during the procedure the surgeon inadvertently cut the graft short which caused the patient complication.

• Brand Name: FLIXENE SLIDER GDS
• Common Device Name: 6MMX50CM FLIXENE GRAFT, GW, W/GDS
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; merrimack NH 03054
• MDR Report Key: 6289951
• Report Number: 1219977-2017-00015
• Device Sequence Number: 13729735
• Product Code: DSY
• UDI-Device Identifier: 00650862250589
• UDI-Public: 00650862250589
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K071923
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2017

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: Physician
• Device Expiration Date: 08/31/2019
• Device Model Number: 25058
• Device Catalogue Number: 25058
• Device Lot Number: 209226
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2017
• Supplement Report FDA Received Date: 02/20/2017
• 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: 76 YR
• Patient Weight: 45