MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE-TEX® SUTURE CV5; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	P5K17A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of the manufacturing records verified that this lot met all pre-release specifications.Two needles, two fibers and one suture carton were returned to the histology facility in the w.L.Gore science center in (b)(4).Images were taken of the returned device and investigated as follow: observations from images: the photographs show the state of the returned device is consistent with the reported complaint of needle separation.The crimped length of the needles appears to be consistent with a normal attachment.On one needle there is evidence of instrument damage.On both fibers one end is torn, typical in reports of needle pull off, and evidence of a formerly secure attachment.A 100% of attachments undergo an in process test at needle attach to ensure that every attachment meets tensile strength requirements.Additionally, each lot is sampled and qc tested for needle attach tensile strength and must meet the release requirements to be dispositioned as accept.The suture hazards analysis, design fmea, and process fmea already address the failure modes and hazardous situations resulting from needle separations.The root cause of the needle separation is that the suture was likely subjected to forces exceeding the tensile strength of the needle attachments.
Event or Problem Description
It was reported to gore that when a gore-tex® suture was used to suture a lesion in the patient¿s mouth, a needle pull off occurred during the procedure.The occurrence did not require a reintervention and no fragments remained in the patient¿s mouth.

• Brand Name: GORE-TEX® SUTURE CV5
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7697491
• Report Number: 3003910212-2018-00061
• Device Sequence Number: 1618466
• Product Code: GAW
• UDI-Device Identifier: 00733132607624
• UDI-Public: 00733132607624
• 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 Assistant
• Type of Report: Initial
• Report Date (Section B): 06/25/2018

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: 06/30/2022
• Device Catalogue Number: P5K17A
• Device Lot Number: 16438306A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• 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: 07/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1