MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE-TEX® SUTURE CV7; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	7M06A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight was requested, but was not available.
Event or Problem Description
It was reported to gore that during a procedure using gore-tex® suture (cv7) as the physician attempted to tie the knot during suturing, the thread broke.It was reported another lot of thread was used to complete the procedure and there was no harm to the patient.
Additional Manufacturer Narrative
Unopened suture devices from the same carton lot were returned to gore, however, the actual device that reportedly knotted during tying was discarded and not returned, therefore an engineering evaluation could not be performed.

• Brand Name: GORE-TEX® SUTURE CV7
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8758289
• Report Number: 3003910212-2019-00190
• Device Sequence Number: 1330343
• Product Code: GAW
• UDI-Device Identifier: 00733132604449
• UDI-Public: 00733132604449
• 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): 07/08/2019

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: 7M06A
• Device Lot Number: 20040647A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• 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: 07/03/2019
• Supplement Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR