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); Itching Sensation (1943); Local Reaction (2035)

Event Date 02/16/2024

Event Type  Injury  

Manufacturer Narrative

Image analysis 3 film images were returned for review.Image 1: ¿image received of a patient¿s leg seemingly with a rash/adverse reaction present, consistent with the reported event.Lot number # of the device could not be confirmed based on the returned image.¿.Image 2: ¿image received of a patient¿s leg seemingly with a rash/adverse reaction present, consistent with the reported event.Lot number # of the device could not be confirmed based on the returned image.¿.Image 3: ¿image received of a patient¿s leg seemingly with a rash/adverse reaction present, consistent with the reported event.Lot number # of the device could not be confirmed based on the returned image.¿.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.

Event Description

A physician used a venaseal closure system to treat vascular reflux in a patient¿s great saphenous vein (gsv).Little vessel tortuosity was reported.The lumen was not flushed prior to use.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.A guidewire was used during catheter insertion and placement.The catheter tip was 5cm caudal to sfj.Tumescent infiltration was not utilized.Local anesthesia was used.No compression was used.The procedure was completed as usual and the vein was reported to have closed.Approximately 3 months post procedure the patient went to the hospital due to delayed allergy.Symptoms were itching with reddening along the glue injection site.Patient was prescribed with prednisone 5 mg/day and locoid cream.Both legs were treated but the reaction was present in only one leg.It was reported that the glue may be in the blood vessels outside the compartment.The patient's complaints disappeared, but the redness remained.The patient visited the hospital for follow up approximately 1 week later, the appearance had not changed but the symptoms had improved.

• 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: 18918936
• MDR Text Key: 337844261
• Report Number: 9612164-2024-01297
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VS-403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• 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