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

Catalog Number VS-402

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930); Skin Discoloration (2074); Skin Irritation (2076)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used a venaseal occluding device during procedure to treat the great saphenous vein (gsv).The lumen was flushed prior to use.Ifu was followed.A guide wire was used for the insertion of the catheter.It was reported that post procedure, patient reported access site issues with irritation, drainage and discoloration.Patient reportedly has a healed access site wound at this time.It was advised to debride the access site for a glue remnant if symptoms re-appear.Antibiotics were prescribed during the initial phase and post procedure.Patient is in follow-up phase with a healed access site wound, which had previously been irritated with drainage and discoloration.No further patient injury reported.

Manufacturer Narrative

Additional information: venaseal treatment was performed in one limb only.The catheter tip was located 5cm caudal to the great saphenous vein prior to initial delivery of adhesive.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the patient had a hypersensitivity reaction within 24 hours of her initial treatment.About three and half months later, the patient went to the hospital after experiencing a 102°f fever and not alerting the facility over the weekend.The physician noticed the patient has terrible cellulitis and needed an iv antibiotic.The patient was sent to a hospital and was prescribed rocephin and vanco.The patient is currently hospitalized.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.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
• MDR Report Key: 9744779
• MDR Text Key: 180635905
• Report Number: 9612164-2020-00852
• 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: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• 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
• Date Manufacturer Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention