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 Itching Sensation (1943); Swelling (2091)

Event Date 02/16/2019

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 received treatment of bilateral great saphenous vein(gsv) and the right anterior accessory great saphenous vein(aagsv) on (b)(6) 2019 using the venaseal closure system.The procedure was reported to have been completed as per ifu.On saturday (b)(6) 2019, patient reported itchiness and saw redness on both legs along the treated parts and had a high temperature.The physician recommended the patient take ibuprofen and paracetamol.The patient reported a blanching rash on the skin developed on the chest but with no cardiac issue.At this point, the patient stopped taking ibuprofen.The patient visited the doctor on mon (b)(6) with a temperature of 38.2c; bp was fine ; heart rate of 80.There was no discharge from the puncture site.Both legs exhibited redness and the blanching rash was observed.Ultrasound showed swelling of the subcutaneous tissues - no gas/liquid was observed there.The doctor prescribed antibiotics.

Manufacturer Narrative

Additional information: approximately 75cm of vein was treated in total (2x gsvs + 1x aagsv).The catheter tip was 5cm caudal to the sapheno femoral junction prior to delivery of adhesive.The physician has also since prescribed antihistamines, and ibuprofen.Patient¿s rash has since disappeared, and made a full recovery.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image analysis: one image was received from the customer.Per the image, patient experience redness in chest , stomach and under the neck.The venaseal device was not returned to analysis lab.The customer experience of patient allergy reaction (hypersensitivity rash) post procedure was confirmed based on the image received.The root cause of the patient allergic reaction post procedure could not be determined.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: 8366501
• MDR Text Key: 137012253
• Report Number: 9612164-2019-00629
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 05/21/2019

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 Catalogue Number: SP-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 02/25/2019
• Supplement Dates Manufacturer Received: 03/26/2019; 05/07/2019
• Supplement Dates FDA Received: 04/11/2019; 05/21/2019
• 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: 54 YR