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

Model Number 25058

Device Problems Kinked (1339); Improper or Incorrect Procedure or Method (2017)

Patient Problem Failure to Anastomose (1028)

Event Date 01/09/2017

Event Type  Injury  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

Event 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.

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
• Type of Device: 6MMX50CM FLIXENE GRAFT, GW, W/GDS
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH 03054 ; 6038645366
• MDR Report Key: 6289951
• MDR Text Key: 66164341
• Report Number: 1219977-2017-00015
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00650862250589
• UDI-Public: 00650862250589
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K071923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 45