MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; INTRODUCER

Model Number	S17-45
Medical Device Problem Codes	Material Fragmentation (1261); Defective Component (2292); Delamination (2904); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been received and is pending a completed evaluation.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Devices remain implanted in the patient.
Event or Problem Description
During the initial implant procedure when the physician removed the introducer delivery system from the patient, a plastic threadlike material was seen coming from the tip of the introducer out of the patient leg.No other material was observed.The physician completed the procedure and the patient is stable.
Additional Manufacturer Narrative
At the completion of the investigation, the clinical evaluation was not completed, there was no known patient injury reported.The manufacturing evaluation did not reveal any issues or deviations that would explain the reported event.Device evaluation was completed and was able to confirm the reported event.Root cause of this event seems to be a manufacturing related issue.

• Brand Name: AFX
• Common Device Name: INTRODUCER
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 5677376
• Report Number: 2031527-2016-00233
• Device Sequence Number: 179930
• Product Code: MIH
• UDI-Device Identifier: 00818009011381
• UDI-Public: (01)00818009011381(17)181116
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2016

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: Health Professional
• Device Expiration Date: 11/16/2018
• Device Model Number: S17-45
• Device Lot Number: 1421496-026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2016
• Supplement Report FDA Received Date: 08/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1