MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. FLIXENE IFG WITH ASSISTED DELIVERY

Model Number 25058

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2014

Event Type  Injury  

Event Description

Received a report that the clear plastic portion of the slider gds that comes connected to the graft came disconnected from the metal connector.This happened while tunneling the graft in a straight configuration av access in a dialysis pt.After the metal tip came disconnected from the clear plastic, the doctor was still able to pull the clear plastic and graft together into proper position.The pt was not harmed.

Manufacturer Narrative

The gds components, which were reported as the cause of the tunneling failure, were not returned to atrium for eval; therefore, the proper functioning of the gds and sheath components cannot be verified.One possible situation for the sheath to become detached, as reported, is the use of a 1:1 sized bullet tip, which would cause extremely tight site to tunnel the graft through.A tight tunneling site as such would create friction and could cause the detachment of the gds mechanisms during tunneling.The lot history of the graft was reviewed and the product was found to have met all specifications.Hosp reported two events.Other event is 1219977-2014-00155.

• Brand Name: FLIXENE IFG WITH ASSISTED DELIVERY
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH
• Manufacturer Contact: theresa morin, mgr. ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3850387
• MDR Text Key: 4412071
• Report Number: 1219977-2014-00156
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: 25058
• Device Catalogue Number: 25058
• Device Lot Number: 200594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2014
• Initial Date FDA Received: 05/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2014
• 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: 66 YR
• Patient Weight: 74