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

Catalog Number SP-101

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

Patient Problems Hematoma (1884); Unspecified Infection (1930); Ulcer (2274); Patient Problem/Medical Problem (2688)

Event Date 08/02/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used venaseal closure system to treat 1 segment of the great saphenous vein (gsv).The ifu was followed during preparation, procedure and post-procedure.The guide wire was used for insertion of the catheter.It was reported the access site closed post procedure, but patient had a hematoma and infection at the access site and had an ulcer develop at this access site.No further patient injury reported for this event.

Manufacturer Narrative

Additional information: physician used venaseal closure system to treat chronic venous insufficiency in right great saphenous vein.1.5mls of adhesive was u sed, the lumen was flushed prior to use.Compression was used.The patient was treated with antibiotics.No further treatment reported.The patient is reported to being well and will be reviewed at the tissue viability unit.The patient was reviewed during a follow-up appointment, it was reported there is significant improvement.The ulcer is doing well.On examination an approximately 1cm ulcer on the medial aspect of the right leg just below the knee was noted.This is clean and there is granulation tissue in the base of the ulcer.There are no signs of infection at present and the wound is dry, but patient appears to be reacting to the sticky part of the mepore dressing so this has not be re-applied.Patient will be reviewed again in two weeks and four weeks and has been advised to regularly change the dressing.Patient is receiving wound care management.Patient discharged following wound care management.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: one image received from customer show ulceration of the access cite.The area of infection showed red/purple color throughout the wound.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: 8892048
• MDR Text Key: 154233696
• Report Number: 9612164-2019-03380
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: MT
• 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: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SP-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2019
• 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: 72 YR