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

Catalog Number VS-403

Device Problem Biocompatibility (2886)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Skin Inflammation/ Irritation (4545)

Event Date 03/03/2023

Event Type  Injury  

Event Description

Venaseal was used to treat a perforator vein of the great saphenous vein (gsv) on the (b)(6) 2023.25 segments were treated and the vein closed.Compression was used and local anesthesia.The procedure was carried out in line of the ifu.One leg was treated.The catheter tip was 5cm caudal to sfj prior to initial delivery of adhesive.Manual long compression of gsv was used.The ifu was followed.It was reported irritation was noted on the (b)(6) 2023 on all limbs, hands and legs.The patient has redness, inflammation, pain and itchiness in left lower limb.The patient has been prescribed steroids and the issue is still present.

Manufacturer Narrative

Product analysis: 10 images were provided for evaluation.One image shows one of the patients arms with what appears to be urticaria "hives" and redness on the inner flexor surface of the arm and forearm.The additional images show the patients legs.Patients legs show dry, red, flaky and irritated skin with possibly some urticaria.The reactions appear to be on both legs, from the anterolateral thigh, to the lower limb, and reaching to the ankle, with one image showing dark discoloration around one of the ankles and dorsal portion of the foot dry, flaky and irritated skin.Images also show the patients forearms and hands, which again, appear to have dry, red, flaky and irritated skin with possibly some urticaria.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: VENASEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16626549
• MDR Text Key: 312103462
• Report Number: 9612164-2023-01307
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VS-403
• Device Lot Number: 69420
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2023
• Date Device Manufactured: 09/20/2022
• 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
• Patient Sex: Female