MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; INTRODUCER

Model Number	S17-45
Medical Device Problem Codes	Material Fragmentation (1261); Delamination (2904); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices involved in the event will not be returned for evaluation.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2016 at the completion of the initial implant of afx devices, a long plastic string was observed coming from the introducer device when removed from the groin area of the patient.The implant procedure was completed and there was no reported injury to the patient.The patient is stable.
Additional Manufacturer Narrative
(b)(4).Based on the information available the root cause of the reported event is unknown.Device was not returned and therefore sample evaluation was not able to confirm the reported events.All reported follow-up information in this report was previously submitted to the fda on 07/25/2017 under incorrect mfr# 2031527-2017-00476 follow-up 001.The follow-up information should have been submitted under this mfr# 2031527-2016-00476 follow-up 001.

• Brand Name: AFX
• Common Device Name: INTRODUCER
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6022662
• Report Number: 2031527-2016-00476
• Device Sequence Number: 13808052
• Product Code: MIH
• UDI-Device Identifier: 00818009011381
• UDI-Public: (01)00818009011381(17)190519
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P040002
• 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): 09/12/2016

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/19/2019
• Device Model Number: S17-45
• Device Lot Number: 1497635-015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/12/2016
• Supplement Date Received by Manufacturer: 09/12/2016
• Initial Report FDA Received Date: 10/12/2016
• Supplement Report FDA Received Date: 05/09/2018
• 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: Other
• Patient Age: 83 YR