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

Catalog Number SP-101

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

Patient Problems Inflammation (1932); Patient Problem/Medical Problem (2688)

Event Date 10/07/2018

Event Type  Injury  

Manufacturer Narrative

One image was returned for evaluation.The image shows blistering, redness, inflammation, and recanalization of a treated site.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician used venaseal to treat the great saphenous vein(gsv).The ifu was followed and the device was prepped without issue.The catheter tip was 5cm below the sapheno femoral junction (sfj) prior to delivery of adhesive.Procedure was completed with a single device without issue and no technical issues were reported during the initial venaseal procedure.The gsv was reported to have closed well and was verified under ultra sound.2 days post procedure, the physician reported that the patient experienced localized phlebitis.Patient had dressings changed <(>&<)> ultrasound carried out 4days post procedure for existing ulcer.Physician noted phlebitis at this time.The physician prescribed nsaid, however the patients pain continued to increase with patient eventually presenting to the er (emergency room) approx.3days later with 2 areas of broken skin under the pressure garment.The two sections of broken skin were observed by the surgeon to be over areas of particularly varicosed superficial veins.Patient remains in hospital receiving treatment for the wounds under physician's management and is responding well to treatment.

• 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: 8059603
• MDR Text Key: 126891070
• Report Number: 9612164-2018-03151
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: SP-101
• Device Lot Number: 52057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2018
• Date Device Manufactured: 07/10/2018
• 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