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 Problem Bruise/Contusion (1754)

Event Date 06/27/2017

Event Type  Injury  

Manufacturer Narrative

Image analysis summary: a series of three photographic images of the patient¿s symptoms were received for evaluation.No components from either venaseal closure system kit was received for evaluation.The photographs confirm significant bruising along the length of the treated vein.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

The physician used a venaseal closure system to treat venous insufficiency in the great saphenous vein under local anesthetic.The lumen was not flushed prior to use.The ifu was followed during prep, procedure and post procedure.A guidewire was used during the insertion of the catheter.Hand compression was used.It was reported that, post op, the patient had significant bruising along the length of the treat vein.The patient was treated with steroids and antibiotics.It was reported that patient¿s condition improved after taking prescribed medications.

• 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: 6766903
• MDR Text Key: 81810910
• Report Number: 3011410703-2017-00303
• Device Sequence Number: 1
• Product Code: PJQ
• UDI-Device Identifier: 10884521539921
• UDI-Public: 10884521539921
• 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: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: VS-402
• Device Lot Number: 42598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2017
• Date Device Manufactured: 10/28/2015
• 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: 62 YR
• Patient Weight: 55