MAUDE Adverse Event Report: SAPHEON INC 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 Inflammation (1932); Pain (1994); Skin Irritation (2076)

Event Date 06/03/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician used a venaseal closure system to close segments in the great saphenous vein under local anesthesia using transducer compression.It was reported that the procedure was completed as normal and the patient did not complain of pain during active treatment.Several days after the procedure, the patient present with skin irritation.It was reported that the skin irritation was present in the distal and middle segment of the thigh, but not in the proximal of the thigh and in the shinbone, although they were also treated.Irritation is reported as being swollen, moderated pain, blush, and very sensitive skin.Pain moderated in middle segment and distal of the thigh.Irritation still present at the time of this report.It was reported that the reaction seems to be phlebitis and local, without systemic involvement.Local heparinoid was prescribed.Reaction reported to be decreased gradually.One month after the procedure, there is still cutaneous involvement.

Manufacturer Narrative

Image analysis: no component of the venaseal closure system kit was returned for evaluation.Two photographic images were received with the initial reported event.The first image is pre-procedure dated (b)(6) 2017.The second image is post-procedure dated (b)(6) 2017.In the second image, there is redness and swelling of the thigh in the area treated with venaseal.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: 6723766
• MDR Text Key: 80377780
• Report Number: 3011410703-2017-00288
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: SP-101
• Device Lot Number: 46230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2017
• Date Device Manufactured: 01/31/2017
• 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: 53 YR
• Patient Weight: 86