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

Catalog Number VS-403

Device Problem Biocompatibility (2886)

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Phlebitis (2004)

Event Date 08/19/2022

Event Type  Injury  

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.

Event Description

A physician used venaseal occluding device during procedure to treat the great saphenous vein (gsv).General anesthesia was used.Hand was used for compression.The vein closed.The lumen was flushed prior to use.Ifu was followed.A guidewire was used for the insertion of the catheter. it was reported that skin irritation occurred near the access point and still present. patient complained of skin tenderness and redness along the treated segment.Patient had venaseal procedure done a year ago for above the knee, no skin irritation or complaint for that procedure.This time patient used venaseal below the knee and complained of skin tenderness and redness along the treated segment.Complication associated with this event was phlebitis after venaseal occlusion.The skin irritation was treated with prescribed steroids.

• 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: 15409362
• MDR Text Key: 299756435
• Report Number: 9612164-2022-03377
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: VS-403
• Device Lot Number: 67136
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2022
• Initial Date FDA Received: 09/13/2022
• Date Device Manufactured: 03/08/2022
• 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: Male