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

Catalog Number VS-402

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2016

Event Type  malfunction  

Event Description

Physician attempted to treat patient at the great saphenous vein using a vena seal device.First vein was treated successfully.It is reported that the vena seal dispenser gun was not working when they were prepping the adhesive for the second vein (bilateral).Physician manually injected the adhesive to complete treatment in the second vein.No patient injury reported.

Manufacturer Narrative

Correction: this event was filed as ¿reportable malfunctions¿ for gun failing to advance following the start of adhesive delivery.On review, it was deemed that the issue of the gun failing to advance following the start of adhesive delivery has never caused or contributed or is likely to cause or contribute to a death or serious injury and therefore do not meet the criteria for a reportable malfunction.This event reported via mdr were due to caution, and thus conservatively reported.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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
• MDR Report Key: 6376251
• MDR Text Key: 69018787
• Report Number: 3011410703-2017-00039
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

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: 01/31/2018
• Device Catalogue Number: VS-402
• Device Lot Number: 43112
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2017
• Initial Date FDA Received: 03/03/2017
• Supplement Dates Manufacturer Received: 03/25/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 87619
• Patient Sequence Number: 1