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

Catalog Number SP-101

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician was attempting to use a venseal occluding device during procedure to treat the great saphenous vein (gsv).The device was reprocessed.The lumen was flushed prior to use.Ifu was followed.A guidewire was used for the insertion of the catheter.It was reported that two legs were treated.The treatment in the first leg was successful.At the second leg, the lock was inserted over the wire.The wire was removed after successful positioning.The catheter was inserted into the slurry and could not be moved further in the second lower third.The catheter was removed from the lock.An attempt was made to get through the lock with the wire.As a result, the wire is broken.The guide wire used is the one supplied by medtronic original.Everything was removed from the leg.Physician completed the procedure with a new venaseal catheter set, the treatment was successfully performed.The vein closed.There was no patient injury.

Manufacturer Narrative

Device evaluation inspection: the blue introducer, dilator, white catheter was returned.The guidewire was returned coiled within its outer sleeve.Blood like substance was noted at the top of the blue introducer and the white catheter.Kinks were noted along the white catheter approx.74.5cm from the distal end of the catheter.Functional testing: the guidewire was removed from its returned sleeve.Per ifu, the guidewire is is a 0.035 in, 180 cm j-wire guidewire.Guidewire was measured using laser scope and is within specification.The returned j-guidewire was measured at 180 cm which is consistent as per the dimensions documented in the ifu.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): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11958615
• MDR Text Key: 255123498
• Report Number: 9612164-2021-02219
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

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: 10/31/2022
• Device Catalogue Number: SP-101
• Device Lot Number: 61600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 06/08/2021
• Supplement Dates Manufacturer Received: 09/21/2021
• Supplement Dates FDA Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1