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

Model Number VS-402

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Skin Irritation (2076); Patient Problem/Medical Problem (2688)

Event Date 11/02/2015

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician used the venaseal to treat the great saphenous vein as per ifu.It was reported the patient presented 11 months post procedure with a red sore area to the mid-thigh area.The physician performed micro-surgery and expressed lymphatic fluid and polymerized adhesive.The event is thought to be a result of a previous procedure where a seldinger technique was used leaving a small puncture in the vein wall.The patient is reported to be fully recovered.

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; north carolina NC 27560
• Manufacturer (Section G): COVIDIEN; 951 aviation parkway; morrisville; north carolina NC 27560
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6124605
• MDR Text Key: 60787327
• Report Number: 2183870-2016-00681
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2016

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
• Device Operator: Health Professional
• Device Model Number: VS-402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2016
• Initial Date FDA Received: 11/23/2016
• Supplement Dates Manufacturer Received: 10/27/2016
• Supplement Dates FDA Received: 09/27/2017
• 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