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

Model Number VS-402

Device Problems Partial Blockage (1065); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2017

Event Type  malfunction  

Event Description

Physician used of venaseal closure system to treat both the right and left gsv under local anesthesia.It was reported that the ifu was followed.Approximately 45cm of the vein on left leg which was closed successfully.It was reported that while treating the right gsv, the venaseal glue gun stopped clicking when trigger was pressed.It was also noticed post procedure that gun plunger was only engaging with trigger sporadically requiring several trigger-pulls to engage the plunger.Two segments were treated and the procedure was ended without closing right gsv.No patient symptoms or complication were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: additional follow-up correspondence revealed that a 15-minute break was taken between the successful treatment of the left gsv and starting the treatment of the right gsv.The 15-minute break was to allow the patient to change position and get comfortable.The primed catheter was removed per instruction for use.The catheter did not appear to be occluded prior to treatment of the right leg.It was reported that 2.5 cc of glue was used to treat the first leg.Evaluation summary: the venaseal closure system was received for evaluation with an adhesive filled syringe attached to the adhesive dispenser gun, the syringe was attached to the venaseal catheter, and the catheter was loaded within an introducer sheath.It was noted that the adhesive syringe barrel was broken.A kink in the catheter was noted just distal of the catheter strain relief.The distal tip of the catheter was occluded with adhesive.A 0.014¿ compatible blunt tip flushing needle could not penetrate the distal tip of the catheter.The venaseal adhesive dispenser gun was opened to allow examination of the plunger.The adhesive dispenser gun was received with the plunger extended out approximately 62mm.The gun trigger was triggered two times and the plunger had advanced outward to approximately 67mm.The plunger was able to be pulled back to t=0 position.The dispenser gun trigger was triggered several times and the plunger had advanced outward to approximately 30mm.The adhesive syringe dispenser gun adapter and syringe were examined.The syringe barrel was noted to be fractured and the syringe plunger was still held with the adhesive gun syringe adapter.The syringe was removed from the dispenser gun syringe adapter.The syringe barrel has fractured just distal of the syringe wings.Cured adhesive was noted at the distal end of syringe barrel.The returned syringe barrel had separated from the syringe barrel wings and confirms the customer experience of component issue.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: 6799694
• MDR Text Key: 82879999
• Report Number: 3011410703-2017-00322
• 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,Followup,Followup
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: VS-402
• Device Catalogue Number: VS-402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2017
• Initial Date FDA Received: 08/16/2017
• Supplement Dates Manufacturer Received: 08/17/2017; 09/21/2017
• Supplement Dates FDA Received: 09/15/2017; 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2017
• 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