MAUDE Adverse Event Report: SAPHEON INC 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 Unspecified Infection (1930); Reaction (2414); Patient Problem/Medical Problem (2688)

Event Date 01/24/2017

Event Type  Injury  

Event Description

The physician used a venaseal closure system on (b)(6) 2017 to treat the gsv of the right leg (5cm from the junction down to the ankle) and approximately 5 stab phlebotomies.The physician reported that the product was used per ifu.There were no challenges or deviations reported in relation to location of catheter tip prior to initial delivery of adhesive.It was reported that patient did well initially.On (b)(6) 2017, a small area of drainage in the calf was observed, a stab evulsion and unroofing of an eschar was performed and the area cultured.The patient was treated with antibiotics (keflex) to treat a superficial e.Coli infection.The wound was healed a week later.On (b)(6) 2017 another area of swelling was observed and the area was opened.There was no pus but bloody drainage was present.On (b)(6) 2017, patient developed cellulitis in the treated area and was admitted, where the physician removed the gsv from the knee to just above the ankle.There was no glue noted outside the vein and the glue appeared as intermittent and in chunks of crystallized translucent pieces in the vein segments.Pus was present in the vein.In addition, the patient has required treatment with immunosuppressant therapy, advanced wound care products and antibiotics.

• Brand Name: VENA SEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): SAPHEON INC; 951 aviation pkwy ste 900; morrisville NC 27560
• Manufacturer (Section G): SAPHEON INC; 951 aviation pkwy ste 900; morrisville NC 27560
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6867761
• MDR Text Key: 86243474
• Report Number: 3011410703-2017-00374
• 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: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• 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
• Date Manufacturer Received: 08/16/2017
• 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: 60 YR