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

Model Number	P6K23A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight was requested, but not provided.The device has not yet been returned for evaluation.Evaluation results will be submitted in the final report.
Event or Problem Description
It was reported to gore that during suturing of a lesion in the mouth using gore-tex® suture, the suture appeared to get longer and thinner until it separated into two pieces.It was reported the procedure was completed using a new suture and there was no impact to the patient.
Additional Manufacturer Narrative
H6: codes updated.Two sections of the device were returned for evaluation.An engineering evaluation was performed and it was noted that devices are covered in residual fluids from the surgery, so visibility of some structures is limited.A review of images provided by gore histology department confirmed that both ends of the thread appeared either elongated or frayed, however the root cause could not be determined.

• 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: 9416813
• Report Number: 3003910212-2019-00499
• Device Sequence Number: 2450397
• Product Code: GAW
• UDI-Device Identifier: 00733132607662
• UDI-Public: 00733132607662
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020

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: 12/31/2023
• Device Model Number: P6K23A
• Device Catalogue Number: P6K23A
• Device Lot Number: 20157433A
• 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: 12/05/2019
• Supplement Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR