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 Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930)

Event Date 07/20/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a patient had a procedure using venaseal to treat 40cm of an incompetent gsv (great saphenous vein) with 3cc of glue, per the ifu.No device issue was reported.No images or procedural notes were available.It was reported that the patient missed the follow-up visit and, when contacted, had been admitted to a hospital with a systemic infection of proteus mirabilis, detected via a venous blood draw.Unaware that the patient had a venaseal treatment, the hospital had misdiagnosed a superficial venous thrombosis(svt).The patient had a mild hypersensitivity in the treatment zone.The patient was hospitalized for 6 days with iv antibiotics and discharged on oral antibiotics.The patient¿s urinary analysis was reported as negative.The patient improved and the reporting physician has stated that they are now doing fine.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; ballybrit; galway,gw
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; ballybrit; galway,gw
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7808244
• MDR Text Key: 117958869
• Report Number: 9612164-2018-02130
• 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
• Report Date: 08/23/2018

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: 07/26/2018
• Initial Date FDA Received: 08/23/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 74 YR