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

Model Number	6M04A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information including id, dob, gender and weight were requested but not made available.While devices were returned, only unopened devices were returned.The engineering evaluation stated: the affected devices were discarded.The remaining unused devices from lot 21063396 were returned to the histology.Since the broken devices were not returned, no images could be taken.The reported issue could not be confirmed.Each device is 100% proof tested in process to confirm a secure needle attachment.Each lot is qc tested for the needle attachment tensile strength characteristic.The test results were reviewed for lot 21063396, and it was confirmed that they were within specification.100% of devices undergo visual inspection at cutting.The thread is inspected for damage or any abnormal condition that would produce a tensile strength anomaly.If the requirements of these inspections were not met the thread would have been rejected.The suture process fmea addresses harms associated with process failure modes that could result in needle separation.
Event or Problem Description
It was reported to gore that during suturing the anastomosis using gore-tex® suture, the needles separated from the threat.It was stated that no needle or suture fragments remained in the patient and that the patient was not harmed.

• 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: 10239157
• Report Number: 3003910212-2020-00111
• Device Sequence Number: 2697264
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2020

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: 6M04A
• Device Catalogue Number: 6M04A
• Device Lot Number: 21063396A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• 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: 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1