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)

Event Date 03/11/2024

Event Type  Injury  

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

A physician used a venaseal closure system during patient treatment.The ifu (instruction for use) was followed during catheter preparation, procedure, post-procedure.The catheter lumen was flushed prior to use.A guidewire was used during catheter insertion and placement and procedure was completed.One leg was treated.No challenges or deviations related to location of catheter tip prior to initial delivery of adhesive.The catheter tip was 5cm caudal to sfj.Compression of gsv was carried out.Approximately 1 week later patient returned for an outpatient visit and no problems were reported.Approximately 2 weeks post treatment the patient reported itching and redness and antihistamine (allegra) medication was prescribed.There was a slight improvement, but no change from previous symptoms.Physician prescribed celestamine.Approximately 1.5 week antihistamine (allegra) medication was prescribed patient reported whole body redness, itching sensation.A drug-induced lymphocyte stimulation test (dlst) was carried out and was negative.2 weeks after the initial medication administeration the patient experienced continued itching and visited the hospital again.Improvement was seen after switching from prednisone prescription to aralax r for 5 days.The patient was discharged from hospital ((b)(6) 2024).The physician reports that the dlst test was negative and allergies were suspected due to the home environment.Due to excessive stress such as keeping an elderly dog indoors and lack of sleep, it appears that things have calmed down by hospitalization.

• 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: 19059414
• MDR Text Key: 339591855
• Report Number: 9612164-2024-01650
• 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: 04/08/2024

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 Catalogue Number: VS-403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/08/2024
• 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