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

Catalog Number VS-402

Device Problem Biocompatibility (2886)

Patient Problems Foreign Body Reaction (1868); Skin Discoloration (2074); Skin Irritation (2076); Swelling (2091); Discomfort (2330)

Event Date 10/21/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient had great saphenous vein (gsv) treated with venaseal.Procedure completed as per ifu.A guidewire was used for insertion of the catheter.Patient returned for follow-up ultrasound 4 days post procedure and showed signs of a rash on legs, abdominal area, and chest.Patient treated with medtrol dose pack, increased prednisone to 40mg and added h2 antagonist, benadryl, and nsaid.The physician has reported rash is improving in lower limbs.

Manufacturer Narrative

Additional information: patient spent 4 days as in patient on iv steroids.Patient is now on 30 mg of steroids daily and symptoms have resolved.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: there were no challenges related to catheter tip prior to initial deliver of adhesive.The catheter was 5cm caudal to the saphenofemoral junction (sfj).The vein closed.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: 9265652
• MDR Text Key: 164601049
• Report Number: 9612164-2019-04589
• 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,Followup
• Report Date: 11/22/2019

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 Catalogue Number: VS-402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/01/2019
• Supplement Dates Manufacturer Received: 11/01/2019; 11/18/2019
• Supplement Dates FDA Received: 11/04/2019; 11/22/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 35 YR