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	01/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing records confirmed that the lot met all pre-release specifications.
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.
Additional Manufacturer Narrative
H6: conclusion code: 61.Engineering evaluation: the photographs show the state of the returned device is consistent with the reported complaint of needle separation.The crimped length of the needle appears to be consistent with a normal attachment, and does not exhibit any signs of instrument damage.There appears to be a small remnant of fiber visible inside the needle bore, 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 attachment.

• 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: 8319608
• Report Number: 3003910212-2019-00026
• Device Sequence Number: 2357418
• 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: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2019

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: 18759105A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• 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: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 60