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

Catalog Number VS-402

Device Problem Biocompatibility (2886)

Patient Problems Unspecified Infection (1930); Skin Irritation (2076); Injury (2348)

Event Date 09/25/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During procedure, physician used venaseal occluding device to treat one segment in the great saphenous vein (gsv).Approximately 2 weeks post procedure, patient suffered skin irritation or burn near the access point.It was reported that irritation type was cellulitis, redness and painful swelling or inflamed at medial thigh.Irritation was treated with medrol dosepack and triamcinolone cream.

Manufacturer Narrative

Additional information: the catheter tip was 5cm caudal from the saphenous femoral junction (sfj).Compression of gsv was performed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the patient is recovering.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: 9138787
• MDR Text Key: 160700125
• Report Number: 9612164-2019-04162
• 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: 11/04/2019

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: VS-402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 10/22/2019; 10/31/2019
• Supplement Dates FDA Received: 10/29/2019; 11/04/2019
• 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: 37 YR
• Patient Weight: 86