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); Pain (1994); Rash (2033); Patient Problem/Medical Problem (2688)

Event Date 05/14/2019

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 physician used a venaseal closure system to treat segments of the great saphenous vein (gsv) on (b)(6) 2019.The procedure was completed on the day without any issue and the ifu was followed during preparation, procedure and post procedure.The patient presented to the physician on (b)(6) 2019 with a rash along the treated area.Physician gave benadryl and medrol.It was reported that the symptoms got worse with autosensitization and rash all over the body with intense itching.Patient was sent to the ed on (b)(6) and was given iv corticosteroids and antihistamines.Treatment with extended course of corticosteroids, topical antihistamines and oral antihistamines continued.Patient has reported itching all over the body.

Manufacturer Narrative

Additional information reported that 30cm of vein was originally treated.Patient has shown marked improvement in itching with prolonged steroids.Patient still experiencing intermittent redness/ blotches on the trunk, face and thighs that disappear in 2-3 days.Patient has not received any further treatment nor is any further treatment planned.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: 8619471
• MDR Text Key: 145367602
• Report Number: 9612164-2019-01807
• 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: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 53926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2019
• Date Device Manufactured: 12/12/2018
• 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: 60 YR
• Patient Weight: 62