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

Catalog Number SP-101

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)

Event Date 04/23/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used a venaseal occluding device during procedure to treat bilateral great saphenous vein (gsv).Approximately one month post procedure, there was no symptom after the procedure, but eczema and itch appeared, and the patient presented in dermatology department same day.On the treated both sides, abdomen and the back of neck, there was eczema and itch sensation.Left eye was found to be bloodshot.Talion and ointment were prescribed.The situation was not improved, so the patient presented in dermatology department again four days later, then prescribed talion and steroid.Since then, improvement was seen, and the patient presented to hospital ten days post initial symptom.Eye-drops was prescribed for the left eye.No further patient injury reported.

Manufacturer Narrative

Additional information: it was reported that 22cm of the right great saphenous vein was treated with 8 treatments administered; 28cm of the left great saphenous vein was treated with 10 treatments administered.The volume of adhesive administered in each leg is unknown.Patient had a follow up consultation 7 weeks post procedure, with the rash and pruritus reported alleviated.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: patient had a follow up consultation 7 weeks after the procedure and the rash and pruritus were alleviated.Image review: four images of received for evaluation.Image 1 shows redness on the patient left and right thigh.Image 2 and 3 show patient left and right thigh.Image 4 shows redness behind the patient neck.Image shows progression of the redness behind patient neck.The redness has improved.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: 9994830
• MDR Text Key: 188792272
• Report Number: 9612164-2020-01678
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: SP-101
• Device Lot Number: 55952
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2020
• Date Device Manufactured: 06/05/2019
• 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