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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Irritation (1941); Pain (1994)

Event Date 04/25/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient received venaseal treatment of the left great saphenous vein (gsv).The patient reported that extensive ultrasounds were taken before and twice post procedure.The patient reported the venaseal was injected by the physician using one hand, while the other was applying periodic/occasional pressure to the vein, after the adhesive was injected, while also observing on ultrasound.The patient experienced pain and discomfort.The patient has reported that it feels like the gsv was filled with medical adhesive rather than glued tightly shut.The patient has reported, prior to receiving venaseal treatment, varicose veins were evident but minimal and very pliable.Following treatment, the patient reports, the top has turned into a hardened ¿double lump¿ approximately 1-1.5 inches in size which is causing great discomfort.The patient has also reported that their gsv now feels like a ¿fishing rod¿.The patient has also reported irritated nerves in addition to pain.No challenges or deviations occurred during the procedure.Ifu was followed.The catheter tip was 5cm caudal to the sapheno femoral junction (sfj).The patient is still experiencing a reported ¿ropey¿ feeling.No further treatment reported.

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: 8798738
• MDR Text Key: 151313824
• Report Number: 9612164-2019-02915
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/02/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 07/17/2019
• Supplement Dates Manufacturer Received: 10/01/2019
• Supplement Dates FDA Received: 10/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention