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

Catalog Number	6K02A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2019 the patient underwent arteriovenous graft placement for hemodialysis using gore-tex® suture.It was reported that the suture frayed and broke intraoperatively, and the needle became disengaged.Reportedly enough throws were tied so that the suture stayed in place upon breaking and all knots reportedly remained intact.The physician tied off at the point of the suture break.The needle was removed and did not remain in the patient.It was reported that the physician is a frequent user of the gore-tex® suture and has much practice with the use of the device.Reportedly the physician did not have a suspected reason for why the suture frayed and broke.Another gore-tex® suture from a different lot was obtained to complete the procedure.There were no further reported issues.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: 9258419
• Report Number: 3003910212-2019-00444
• Device Sequence Number: 2055050
• Product Code: GAW
• UDI-Device Identifier: 00733132603831
• UDI-Public: 00733132603831
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P820083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/02/2019

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: 06/30/2024
• Device Catalogue Number: 6K02A
• Device Lot Number: 20756531A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1