MAUDE Adverse Event Report: MEDTRONIC IRELAND VENA SEAL CLOSURE SYSTEM; AGENT, OCCLUDING, VASCULAR, PERMANENT

Catalog Number VS-402

Device Problem Mechanical Problem (1384)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/06/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician intended to use a venaseal kit to treat the great saphenous vein.Ifu was followed.It was reported that a very small amount of adhesive was delivered to the site and was confirmed using ultrasound however after this first aliquot the dispensing gun would not engage and move forward to continue to treat the patient.The physician tried multiple times before removing the device.Another venaseal kit was used to complete the procedure.

Manufacturer Narrative

Device analysis: the venaseal component dispenser was returned for evaluation within its transportation tray taped over with its inner label.No other components were returned.Visual inspection of the dispenser gun revealed no abnormalities or deformities.Functional testing was performed.A syringe was attached to the dispenser.During the first test and after 17 trigger pulls, the plunger stopped at 3ml and would not advance to the tip of the syringe.During the 2nd trigger test, all screws were tightened, and the plunger would only advance to the 1ml mark of the syringe after 55 triggers and was unable to advance to the tip of the syringe.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction: this event was filed as ¿serious injuries¿ for non-specific/non serious injury due to incoming information relating to gun failures.Information for these events suggested that the treatment had been incomplete, the treated veins were described as not fully closed.On review of all the data, there was no allegation in this event that the venaseal device caused or contributed to a serious injury.In addition, it has been determined that the event does not meet the criteria for a reportable malfunction.This event reported via mdr were due to caution, and thus conservatively reported.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): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8174990
• MDR Text Key: 130682502
• Report Number: 9612164-2018-03688
• 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,health
• Remedial Action: Notification
• Type of Report: Initial,Followup,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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: VS-402
• Device Lot Number: 52801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 02/01/2019; 03/25/2021
• Supplement Dates FDA Received: 02/20/2019; 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 87619
• Patient Sequence Number: 1
• Patient Outcome(s): Other