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

Catalog Number VS-402

Device Problem Biocompatibility (2886)

Patient Problem Rash (2033)

Event Date 12/09/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Patient successfully treated with venaseal with favorable outcome.3 weeks later patient returned for second venaseal treatment of great saphenous vein (gsv).12 days post second venaseal treatment, the patient returned complaining of a full body rash.The patient was given medrol and the symptoms are reported to have cleared up.No additional treatment required.

Manufacturer Narrative

Aware date should be 13 mar 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

Patient successfully treated with venaseal with favorable outcome.3 weeks later patient returned for second venaseal treatment of great saphenous vein (gsv).12 days post second venaseal treatment, the patient returned complaining of a full body rash.The patient was given medrol and the symptoms are reported to have cleared up.No additional treatment required.No further injury reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9519342
• MDR Text Key: 172803667
• Report Number: 9612164-2019-05298
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VS-402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 03/13/2020; 03/13/2020
• Supplement Dates FDA Received: 03/18/2020; 03/18/2020
• 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