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 Problems Phlebitis (2004); Reaction (2414)

Event Date 03/28/2017

Event Type  Injury  

Manufacturer Narrative

Photograph evaluation summary: no components from the venaseal closure system kit was received for evaluation.A photographic image of the patient¿s symptoms was received for evaluation.The photograph shows redness on the patient¿s leg where the vein was treated.The customer experience of a patient having a reaction to the venaseal closure system adhesive was confirmed.A photographic image was provided for review and shows redness of the patient¿s skin in the area of the vein treated with the venaseal closure system.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 device to perform a vein closure procedure of the great saphenous vein, as per ifu with no issues noted.The patient attended a follow up appointment, it was reported the patient presented with post procedure phlebitis and blistering.Patient was treated with topical steroids.It was reported all symptoms cleared after the treatment.

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 pkwy ste 900; morrisville NC 27560
• Manufacturer (Section G): COVIDIEN; 951 aviation pkwy ste 900; morrisville NC 27560
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6546351
• MDR Text Key: 74472623
• Report Number: 3011410703-2017-00168
• Device Sequence Number: 1
• Product Code: PJQ
• 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
• Report Date: 04/05/2017

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
• Device Operator: Health Professional
• Device Model Number: VS-402
• Device Lot Number: 40495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2017
• Initial Date FDA Received: 05/04/2017
• Supplement Dates Manufacturer Received: 04/05/2017
• Supplement Dates FDA Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Other