MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE-TEX® SUTURE CV7; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	P7K13A
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to gore that during a connective tissue graft procedure using gore-tex® suture, item# p7k13a/15829623a, two sutures broke as the suture was being pulled through the gum.It was reported the thread broke near the end of suturing and the remaining piece of suture was cut off and discarded.It was reported that a different lot of sutures was used to complete the procedure and there was no impact to the patient.

• Brand Name: GORE-TEX® SUTURE CV7
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7785194
• Report Number: 3003910212-2018-00072
• Device Sequence Number: 2049739
• Product Code: GAW
• UDI-Device Identifier: 00733132607686
• UDI-Public: 00733132607686
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P820083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2018

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: 12/31/2021
• Device Catalogue Number: P7K13A
• Device Lot Number: 15829623A
• Was Device Available for Evaluation?: No
• 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: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 63