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

Model Number VS-402

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

Patient Problem Reaction (2414)

Event Type  Injury  

Event Description

It was reported that a vein closure procedure was successfully performed on a patient¿s left leg using a venaseal device, on (b)(6)2016.Later, on (b)(6) 2017, another vein closure procedure was carried out on the same patient, this time on his right gsv.The vein was reported to be successfully closed.On (b)(6) 2017, patient underwent another ablation procedure of right lower extremity perforator veins with a sclerosing solution, sotradecol.On (b)(6) 2017, patient complained of pain, swelling and redness in his left medial calf.Patient was treated with naproxen, an nsaid.On (b)(6) 2017, patient complained of worsening pain and redness.On (b)(6) 2017, patient developed a blister at the site of inflammation; this blister eventually burst and became an open wound.Patient was treated with naproxen, medrol dosepack (steroid), and benadryl (anti-histamine).On (b)(6) 2017, a significant improvement was noticed on patient's wound; redness and inflammation had decreased.Patient was re-treated with medrol dosepack, naproxen and benadryl.On (b)(6) 2017, redness and swelling returned.It was reported that patient will see a dermatologist for further treatment of possible contact dermatitis.

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): COVIDIEN; 951 aviation parkway; morrisville NC 27560
• Manufacturer (Section G): COVIDIEN; 951 aviation parkway; morrisville NC 27560
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6390338
• MDR Text Key: 69437818
• Report Number: 3011410703-2017-00041
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: VS-402
• Device Catalogue Number: VS-402
• Device Lot Number: 40271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• Date Device Manufactured: 07/24/2015
• 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
• Patient Age: 41 YR