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

Model Number	7M04A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified that the lot met all pre-release specifications.While it was stated that the device was returned, the return only included the carton and bac-cards.So, images of the actual device were not available for review.Because of this, the failure could not be confirmed.Per the instructions for use (ifu) for gore-tex® suture, when tying knots with the gore-tex® suture, tension should be applied by pulling each strand of the suture in opposite directions with equal force.As the knot is tensioned, the air in the suture is forced out.Care should be taken to avoid using a jerking motion which could break the suture.Uneven tensioning of a well formed square knot may result in an unsecure knot.When the gore-tex® suture is properly tensioned and formed, standard surgical knotting techniques will produce a secure knot.
Event or Problem Description
It was reported to gore that during an arteriovenous graft (avg) while using gore-tex® suture, the suture broke when the physician went to tie it.Reportedly, upon tying the final knot, the suture broke along the course of the anastomosis, not at the knot.It was reported the anastomosis was redone.It was reported the procedure was completed without difficulty.

• Brand Name: GORE-TEX SUTURE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10750908
• Report Number: 3003910212-2020-01122
• Device Sequence Number: 19843299
• Product Code: GAW
• UDI-Device Identifier: 00733132604425
• UDI-Public: 00733132604425
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P820083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/28/2020

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: 06/30/2024
• Device Model Number: 7M04A
• Device Catalogue Number: 7M04A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/28/2020
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 67