MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE-TEX® SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	6M02A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Information related to the case was requested, however no information has been received.
Event or Problem Description
It was reported to gore that during carotid cases using gore-tex® suture, several sutures frayed.No patient harm was reported.
Additional Manufacturer Narrative
The engineering evaluation stated: because the device was discarded at the hospital, it was not possible to perform a physical analysis of the device that would include images.Existing controls to prevent occurence of reported issue: 100% of devices undergo visual inspection at cut thread inspection and a tactile inspection prior to loading.If the requirements of these inspections were not met the product would have been rejected.Risk documents review: the suture hazards and harms analysis, design fmea, and process fmea already address the failure mode and hazardous situations resulting from frayed devices.Other tasks for the event: manufacturing records were reviewed and indicated that the reported lot met all pre-release specifications.Additionally, manufacturing records were reviewed for the associated cut thread lot and indicated that the lot met all pre-release specifications.No ncr or other quality objects were associated with the lot.Root cause: based on the investigation, the root cause of the frayed suture is not able to be determined.
Additional Manufacturer Narrative
A1- patient identifier added.

• Brand Name: GORE-TEX® SUTURE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9694197
• Report Number: 3003910212-2020-00020
• Device Sequence Number: 1743030
• Product Code: GAW
• UDI-Device Identifier: 00733132603954
• UDI-Public: 00733132603954
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P820083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2020

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: 06/30/2023
• Device Model Number: 6M02A
• Device Catalogue Number: 6M02A
• Device Lot Number: 18372381A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/26/2020; 04/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1