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 Erythema (1840); Irritation (1941); Skin Irritation (2076); Reaction (2414)

Event Date 06/29/2018

Event Type  Injury  

Manufacturer Narrative

Implant date approximate based on information received.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that a patient was treated with approx.1.3cc of vena seal adhesive for a great saphenous vein (gsv) lesion as per the ifu.There were no issues during the procedure.Three days post procedure the skin presented with skin irritation appearing high up in the treated leg.The patient was given antibiotics but the redness was reported to be present.The patient is reported to be doing fine.

Manufacturer Narrative

Additional information: event date (b)(6) 2018, implant date (b)(6) 2018.Photograph evaluation: no components from the venaseal closure system kit were received for evaluation.An image was received - bruising is can be seen in the image received.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 7717463
• MDR Text Key: 114933738
• Report Number: 9612164-2018-01850
• 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: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• 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: 08/08/2018
• 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