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 Problem Inflammation (1932)

Event Date 05/02/2018

Event Type  Injury  

Manufacturer Narrative

One photographic image of the patient¿s treated right leg was received.The photograph confirms bruising and inflammation on a venaseal treated leg.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient was treated with venaseal and the procedure was completed without issue.At a follow up appointment, the patient had a scan and it was noted that the patient had a large area of painful induration in area of branch varicosity, coming off the great saphenous vein (gsv).The patient was allergic to lidocaine, so it could not be punctured and drained and patient did not want oral steroids.The branch was compressible, and one could see small amounts of glue in it.The patient was given a local steroid injection (kenelog) into the affected vein.The patient had improvement in symptoms in 24 hours and was pleased.The physician has regularly used this steroid on all types of inflammatory areas.The physician stated the area of irritation was a ¿bucket handle¿ type of branch vein up near the sfj.Physician believed it was a combination of superficial thrombophlebitis and foreign body response.

• 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: 7552747
• MDR Text Key: 109509869
• Report Number: 9612164-2018-01267
• 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
• Report Date: 05/30/2018

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 Expiration Date: 02/28/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 50544
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/30/2018
• Date Device Manufactured: 02/20/2018
• 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