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

Model Number VS-402

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 05/30/2017

Event Type  Injury  

Event 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.

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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): COVIDIEN; 951 aviation parkway; morrisville NC 27560
• Manufacturer (Section G): COVIDIEN; 951 aviation parkway; morrisville NC 27560
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6675924
• MDR Text Key: 78652284
• Report Number: 3011410703-2017-00271
• Device Sequence Number: 1
• Product Code: PJQ
• UDI-Device Identifier: 10884521539921
• UDI-Public: (01)10884521539921(17)171231(1
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR