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 Problems Unspecified Infection (1930); Skin Irritation (2076); Patient Problem/Medical Problem (2688)

Event Date 04/22/2019

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 patient had treatment on the below knee great saphenous vein(gsv) and short saphenous vein(ssv) with a venaseal closure system.Local anesthesia was used with no compressions.The procedure was completed without incident.There was no alleged product issue.Approximately 3 weeks post onset of symptoms, the patient presented with an infection at the access site.Redness and induration was seen extending the length of the gsv along with infection.The physician resected the below knee gsv.

Manufacturer Narrative

Additional information: the catheter tip was 5cm caudal to the sapheno femoral junction (sfj) prior to delivery of adhesive.The vein is reported to have closed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: 3cc of glue was used to treat 9cm of the gsv as per ifu.The patient was prescribed augmentin and is reported to be doing well, vein was excised.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: 8603535
• MDR Text Key: 144821718
• Report Number: 9612164-2019-01706
• 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: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VS-402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2019
• 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
• Patient Age: 70 YR
• Patient Weight: 80