MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE-TEX® SUTURE CV6; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	6M04A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unused/unopened devices from the same lot were returned, however, the actual device used in the procedure was reportedly discarded at the hospital.Since the device was discarded, it was not possible to perform a physical analysis of the break site.100% of devices undergo visual inspection and a tactile inspection.Samples are taken from each lot and tested for knotted tensile strength.Each device undergoes a 100% in process tensile.If the requirements of these inspections were not met the product would have been rejected.
Additional Manufacturer Narrative
Patient information was requested, but not provided.The instructions for use for gore-tex® suture provides the following precautions among others, "care should be taken to avoid using a jerking motion which could break the suture.".
Event or Problem Description
The following was reported to gore: during a fem.Tea with bovine patch (a.Femoralis), the gore-tex® suture tore from the needle after two stitches were completed.The procedure was reportedly finished with a suture from a different lot.It was stated the patient tolerated the procedure.

• Brand Name: GORE-TEX® SUTURE CV6
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9340407
• Report Number: 3003910212-2019-00476
• Device Sequence Number: 11443568
• Product Code: GAW
• UDI-Device Identifier: 00733132603978
• UDI-Public: 00733132603978
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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: 12/31/2023
• Device Catalogue Number: 6M04A
• Device Lot Number: 20212963A
• 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
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1