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

Catalog Number VS-402

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

Patient Problems Itching Sensation (1943); Rash (2033); Swelling (2091); Patient Problem/Medical Problem (2688)

Event Date 07/05/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had a venaseal procedure carried out on the left leg on july 1st.By july 8th, the left leg was reported to have swollen and was red and itchy.On july 10th, the rash was reported to have spread to the entire body and became brighter and the itchiness increased.Patient consulted with the vascular surgeon, primary doctor, rhuematologist and immunologist.High doses of prednisone were prescribed by the immunologist which has led to a decrease in the itchiness.

Manufacturer Narrative

Information related to this event previously reported in 9612164-2019-02815 additional information: patient had entire great saphenous vein (gsv) treated with venaseal.One day post procedure the patient received an infusion for the pre-existing rheumatoid arthritis (ra).3 days post infusion the patient broke out in mild hives and itching over her trunk, shoulders and arms patient also has some mild redness over the venaseal treated vein.The physician carrying out the infusion deemed the cause was secondary to the infusion treatment and not the venaseal treatment and placed her on oral steroids and pain medication.The venaseal physician believes this is the case as well.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): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8845711
• MDR Text Key: 152779217
• Report Number: 9612164-2019-03142
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VS-402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2019
• 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