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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 08/21/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient underwent venaseal treatment on both legs.1 day post procedure, the right leg developed blisters in the lower portion after removing the ace wrap that was put on by the clinic.The patient has described a series of little bubbles on right leg post procedure, looks like water liquid color its not blood, maybe ulcers.The patient had contacted the implanting physician, but physician is not clear as to why the little pimples are occurring.They take maybe a week and dry up and go away.Patient gives the ulcers time and let it dry up.The blisters have not completely cleared.The patient visited the physician after the blisters and received prescribed silver alginate ointment and otc frankincense essential oils.After 1.5 - 2 months, the blistered areas had healed and the issue has fully resolved.It is suspected the cause was from the compression ace bandage placement rather than the venaseal treatment.It is possible the venaseal may be a cause but it is reported that this type of reaction in a 24 time period is unusual.No further patient injury reported.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10769097
• MDR Text Key: 214150243
• Report Number: 9612164-2020-04179
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/02/2020

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/02/2020
• 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