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 Problem Hypersensitivity/Allergic reaction (1907)

Event Date 07/27/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had 45 segments of great saphenous vein (gsv) treated with venaseal on (b)(6) 2018.Compression of the gsv was applied during procedure, not post procedure, and the vein was reported to have closed with no issues.There was no issue locating the catheter tip prior to initial delivery of adhesive and the catheter tip was 5cm caudal to the sjf (saphenofemoral junction).On (b)(6) 2018, the patient presented to er with hypersensitivity in the form of redness at the site to distal thigh.The patient was given antibiotics - 500mg of keflex and sent home.The er physician diagnosed this as cellulitis.The patient was seen 3 days later and had a pain score of 7 with redness but not warm to touch.The scan showed complete closure.The physician prescribed nsaids - two pills twice daily for 2 days.The physician stated that the glue may have been dragged into the derma when taking the device out of the patient.The symptoms experienced by the patient have been resolved and the patient is doing better.

• 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: 7817759
• MDR Text Key: 118270257
• Report Number: 9612164-2018-02181
• 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: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 51767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2018
• Date Device Manufactured: 06/21/2018
• 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