MAUDE Adverse Event Report: COVIDIEN VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT

Model Number	VS-402
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/30/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician used the venaseal to treat the great saphenous vein as per ifu.The procedure was completed successfully at the time.It was reported the patient presented with an infection at the access site 12 months post procedure.The patient was treated with oral antibiotics and antibiotic cream.
Additional Manufacturer Narrative
Additional information: the total treatment length was approximately 33cm, and the cyanoacrylate glue used for the procedure was approximately 1.2ml.Patient had no known allergies.Patient is currently doing better after the antibiotic treatment.Image analysis: a single photographic image was provided.The photograph is of the injection site.The injection site exhibits redness and appears to be weeping clear fluid.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Common Device Name: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): COVIDIEN; 951 aviation parkway; morrisville NC 27560
• MDR Report Key: 6675924
• Report Number: 3011410703-2017-00271
• Device Sequence Number: 72062
• Product Code: PJQ
• UDI-Device Identifier: 10884521539921
• UDI-Public: (01)10884521539921(17)171231(1
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P140018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: VS-402
• Device Catalogue Number: VS-402
• Device Lot Number: 42899
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: 07/20/2017; 07/20/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 08/18/2017; 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR