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 Skin Irritation (2076); Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Date 07/25/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: month and year only valid.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician used a venaseal closure system to treat segments of the great saphenous vein (gsv) in (b)(6) 2019.The procedure was completed on the day without any issue and the ifu was followed during preparation, procedure and post procedure.A guidewire was used for the insertion of the catheter.Post procedure, when the patient presented for the 6 month check up, there was skin irritation noticed near the access site.Patient will be scheduled for surgery to excise the foreign body noticed.

Manufacturer Narrative

Image review: a single photographic image of the patient¿s left leg was received for evaluation.Redness surrounding an eschar is present at the access site in the photograph.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the foreign body has been excised from the patient.The foreign body was described as a 4mm pellet which was located just under the skin.The patient is reported to be fine now.No medications prescribed.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: 8836771
• MDR Text Key: 152501851
• Report Number: 9612164-2019-03095
• 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: 09/27/2019

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
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 52491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2019
• Initial Date FDA Received: 07/29/2019
• Supplement Dates Manufacturer Received: 07/30/2019; 09/26/2019
• Supplement Dates FDA Received: 07/31/2019; 09/27/2019
• Date Device Manufactured: 08/22/2018
• 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