MAUDE Adverse Event Report: SAPHEON INC VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT

Model Number SP-101

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

Patient Problem Reaction (2414)

Event Date 08/03/2017

Event Type  Injury  

Manufacturer Narrative

Analysis of images: nine photographs of the treated leg were provided.Pictures show that the treated leg exhibits redness and blistering.

Event Description

Physician used a vena seal closure system to perform a vein closure treatment using of the gsv.It was reported that two segments of the vein were treated and the procedure went as normal and was completed successfully.One week after the procedure, the patient experienced an allergic reaction, and was prescribed antihistamines, but these had no effect.Patient visited a local emergency room (er) and was administered iv steroids.This reduced the allergic reaction.At a follow-up appointment with the physician 3 days following this, the patient remembered she had an allergy to acrylic (from previous use of acrylic used in nails).

Manufacturer Narrative

Patient age: reported as (b)(6) years.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): 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: 6840553
• MDR Text Key: 84614028
• Report Number: 3011410703-2017-00359
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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
• Report Date: 09/07/2017

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 Model Number: SP-101
• Device Catalogue Number: SP-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2017
• Initial Date FDA Received: 09/02/2017
• Supplement Dates Manufacturer Received: 09/07/2017
• Supplement Dates FDA Received: 10/07/2017
• 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: 49 YR