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

Catalog Number	P5K23A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing records confirmed that the lot met all pre-release specifications.The photographs show the state of the returned device is consistent with the reported complaint of needle separation.There are remnants of fiber visible inside both needle bores, typical in reports of needle pull off, and evidence of a formerly secure attachment.Existing controls to prevent occurence of reported issue: 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.Risk documents review: the suture hazards analysis, design fmea, and process fmea already address the failure modes and hazardous situations resulting from needle separations.Root cause: the root cause of the needle separation is that the suture was likely subjected to forces exceeding the tensile strength of the needle attachments.As additional information revealed that in total three gore-tex® suture devices were involved in the medical device incident, two additional reports will be send to the fda under mfr report #3003910212-2019-00025 and mfr report #3003910212-2019-00009.As date of event couldn¿t be confirmed the year 2018 will be used as ¿year of event¿.
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.This happened three times with three sutures of the same lot number each time.The occurrence did not require a reintervention and no fragments remained in the patient¿s mouth.
Additional Manufacturer Narrative
Correction of conclusion code 4316 to 4315.

• 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: 8319599
• Report Number: 3003910212-2019-00024
• Device Sequence Number: 19422424
• Product Code: GAW
• UDI-Device Identifier: 00733132607648
• UDI-Public: 00733132607648
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2019

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: 06/30/2023
• Device Catalogue Number: P5K23A
• Device Lot Number: 18640419A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• 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: 02/08/2019
• Supplement Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1