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

Model Number VS-402

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2020

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 during treatment of the patient¿s great saphenous vein (gsv).Ifu was followed.A guidewire was used for insertion of the catheter.It is reported after placing grey dilator and blue introducer 5cm from the junction the grey introducer was left in place and the venaseal delivery catheter was placed into blue introducer.When visualised under ultrasound to confirm placement of delivery catheter, a solid bright white object appeared under ultrasound at tip of the catheter and blue introducer.The delivery catheter was pulled out and object was still showing under ultrasound, so physician used a strainer catheter to catch/hook the object and pull it into the blue introducer.This object was removed within the blue introducer.The patient was bandaged up and the procedure was aborted.No injury reported.

Manufacturer Narrative

Product analysis: the venaseal system was returned to medtronic investigation lab for analysis.The device was received inside a biohazardous packaging with the venaseal pouch which indicated lot number.A non-medtronic strainer catheter was included.A visual inspection of the returned components did not find evidence of a fracture where a portion of the components may have embolized.All venaseal components remained intact.The distal rim for each component was inspected under microscope and found no anomalies.Traces of dried blood was observed within all of the returned components.The blue introducer showed kinks at approximately 35 and 77.5cm from the distal tip.It is likely the observed kinks occurred during post-procedural handling when the introducer was wrapped.Image review: the customer provided multiple sonogram videos from the procedure.The videos show various phases from the procedure.The last video shows a piece of potential debris being captured within the introducer.The origin of the unknown material could not be determined.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
• MDR Report Key: 10704132
• MDR Text Key: 212085392
• Report Number: 9612164-2020-04010
• Device Sequence Number: 1
• Product Code: PJQ
• UDI-Device Identifier: 00643169986268
• UDI-Public: 00643169986268
• 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
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

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: 01/31/2022
• Device Model Number: VS-402
• Device Catalogue Number: VS-402
• Device Lot Number: 58570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 03/23/2021
• Supplement Dates FDA Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention