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

Catalog Number VS-402

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling (2091)

Event Date 03/06/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used venaseal occluding device during procedure to treat bilateral great saphenous vein (gsv).The ifu was followed.It was reported that procedure was completed.Patient developed reaction a week later.Patient had venaseal on bilateral gsv's.Patient had a reaction to the glue of redness, itching, swelling and blistering.Patient was checked for dvt , but ultrasound was negative.Patient was put on antibiotics and told to take over the counter benadryl.Patient stated that after taking benadryl the itching subsided.Took almost 3 weeks for side effects to completely go away.23cm of the right great saphenous vein and 35cm of the left great saphenous vein were treated in separate procedures, with approximately one week between treatments.The total volume of adhesive administered is unknown.There were no challenges or deviation in relation to location of catheter tip prior to initial delivery of adhesive and the catheter was 5cm caudal to the saphenous femoral junction.Compression of gsv was performed.The reaction was observed along the treated area, knee to ankle ble.The issue has resolved and the patient is doing fine.Both legs had the reaction noted.There was no further patient injury reported.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10160790
• MDR Text Key: 195374155
• Report Number: 9612164-2020-02213
• 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: 06/16/2020

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: 06/30/2021
• Device Catalogue Number: VS-402
• Device Lot Number: 55955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 06/16/2020
• Date Device Manufactured: 06/07/2019
• 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
• Patient Age: 61 YR
• Patient Weight: 90