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

Catalog Number VS-402

Device Problem Biocompatibility (2886)

Patient Problems Hypersensitivity/Allergic reaction (1907); Injury (2348)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used venaseal to treat patient¿s great saphenous vein (gsv).Ifu was followed.The vein is reported to have closed.4 days post-procedure, the patient contacted the clinic reporting symptoms of redness, swelling and heat.The patient was asked to draw a line around the redness.The patient returned to the clinic one day later, with cellulitis like symptoms and the redness had expanded by inches.The patient has been prescribed keflex.

Manufacturer Narrative

Additional information: the left leg was treated.The catheter was positioned 5cm caudal to the sfj prior to delivery of adhesive.When patient first called reporting symptoms, prior to returning for follow-up, they were advised to take ibuprofen and the itching is reported to have resolved somewhat.The physician described erythema as being rather rosy red.Hypersensitivity reaction suspected.Benadryl was also prescribed during follow-up visit.Patient had a follow up consultation one week after the beginning of symptoms and the condition has completely resolved.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

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: 9160823
• MDR Text Key: 161786469
• Report Number: 9612164-2019-04246
• 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,Followup
• Report Date: 01/17/2020

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 Expiration Date: 12/25/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 53844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 10/09/2019; 10/16/2019; 01/16/2020
• Supplement Dates FDA Received: 10/11/2019; 10/17/2019; 01/17/2020
• Date Device Manufactured: 12/05/2018
• 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 Age: 70 YR
• Patient Weight: 88