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

Catalog Number VS-402

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician used venaseal to treat 2 segments in the right great saphenous vein(gsv) of the patient.The ifu was followed and the device was prepped without issue.The catheter tip was 5cm caudal to the sapheno femoral junction (sfj) prior to initial delivery of adhesive.The gsv was compressed during the procedure.It was reported the vein did close.There were no issues reported at time of the procedure.Approximately 7 weeks later on (b)(6) 2018, the patient was reported to have developed an infection at the access site on the upper thigh.The patient was given doxycycline and bactrim.A little over 2 weeks later, on (b)(6) 2018, following prescription of the doxycycline and bactrim, the patient attended a follow up visit - there was no complaint of infection at this visit.Bilateral ultrasound was completed and there was no documentation of redness, pain or swelling.No medication was prescribed, at this time.Almost 2 months later, on (b)(6) 2018, the patient was reported to have developed a scab with pain, redness and swelling.Patient was then put on a second round of bactrim and doxycycline.

• 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: 8019712
• MDR Text Key: 125496527
• Report Number: 9612164-2018-02986
• 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
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 51017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2018
• Date Device Manufactured: 04/05/2018
• 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