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); Pain (1994); Phlebitis (2004)

Event Date 10/25/2023

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 venaseal closure system was used for treatment for 8 segments of the great saphenous vein (gsv) on the (b)(6) 2023.No tumescent i nfiltration was used, local anesthesia and hand compression was used.The ifu was followed and the vein was reported as closed.There were no challenges or deviations related to the location of the catheter tip prior to initial delivery of adhesive.The catheter tip was 5cm caudal to sfj.Compression of gsv was applied.It was reported during a follow-up on the (b)(6) 2023 the patients thigh was red and painful, only the right leg was treated and affected.The physician stated it is likely to be vein phlebitis /delayed hypersensitivity.The patient was prescribed nsaid's and anti-histamine.Issue resolved on (b)(6) 2023.

Manufacturer Narrative

Image analysis 5 film images were returned for review.Image 1: ¿image received of patient¿s leg.Slight redness appears to be present on the inside of the leg, consistent with the reported event.Lot number # of the device could not be confirmed based on the reported event.¿.Image 2: ¿image received of patient¿s legs.A slight reaction appears to be present on the right leg only, consistent with the reported event.Lot number # of the device could not be confirmed based on the reported event.¿.Image 3: ¿image received of patient¿s legs with no apparent issues noted, not consistent with the reported event.Lot number # of the device could not be confirmed based on the reported event.¿.Image 4: ¿image received of patient¿s leg.Slight redness appears to be present on the inside of the leg, consistent with the reported event.Lot number # of the device could not be confirmed based on the reported event.¿.Image 5: ¿image received of patient¿s leg.Slight redness and reaction appears to be present along the inside of the leg, consistent with the reported event.Lot number # of the device could not be confirmed based on the reported event.¿.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: 18309997
• MDR Text Key: 330276676
• Report Number: 9612164-2023-05890
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• 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: 72172
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• Date Device Manufactured: 05/03/2023
• 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