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 Pain (1994); Reaction (2414); Patient Problem/Medical Problem (2688)

Event Date 06/09/2017

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

The physician intended to use a venaseal closure system pack for a vein closure procedure of the right great saphenous vein (gsv).The gsv was accessed with standard technique and a sheath.The 0.035'' j wire was inserted through the sheath.The 0.035'' wire, the 7 fr sheath and the red entry needle from the venaseal pack were used and came in contact with the patient.The patient complained of pain around their right knee.The j wire was removed.It was reported that patient then complained of nausea.The procedure was paused to observe the patient.It was reported that a few minutes later, the patient had difficulty breathing.The physician treated patient for anaphylaxis using adrenaline, phenergan and hydrocortisone, and the patient was admitted to hospital.No venaseal adhesive was administered to the patient.

Manufacturer Narrative

Patient is doing well.Physician reported that the patient is more likely to be allergic to lignocaine than betadine.An approximation of the patient's weight form the physician.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 parkway; morrisville NC 27560
• Manufacturer (Section G): SAPHEON INC; 951 aviation parkway; morrisville NC 27560
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6694540
• MDR Text Key: 79350171
• Report Number: 3011410703-2017-00276
• Device Sequence Number: 1
• Product Code: PJQ
• UDI-Device Identifier: 10884521544918
• UDI-Public: (01)10884521544918(17)171231(1
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/21/2017

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 Expiration Date: 12/31/2017
• Device Catalogue Number: SP-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2017
• Initial Date FDA Received: 07/07/2017
• Supplement Dates Manufacturer Received: 08/21/2017
• Supplement Dates FDA Received: 09/19/2017
• Date Device Manufactured: 12/15/2015
• 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): Hospitalization; Required Intervention
• Patient Weight: 75