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

Model Number VS-402

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2020

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 venaseal occluding device during procedure to treat 55cm of the great saphenous vein (gsv).Ifu was followed.A guide wire was used in the insertion of catheter.It was reported that the delivery catheter and gun were prepped according to ifu.After multiple successful deliveries of adhesive and prior to removal of venaseal delivery catheter from patient, final delivery was attempted and trigger was pulled, although the syringe plunger did not move forward, no more adhesive entered the delivery catheter.After multiple unsuccessful attempts at depressing the trigger on gun with no adhesive advancing, physician elected to end the procedure and remove the device from the patient.Patient treated successfully and was unharmed.There was no patient injury reported.

Manufacturer Narrative

Additional information: the issue occurred at end of procedure and the desired length of treatment had already been completed.The vein is reported to have closed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: the venaseal was returned to medtronic investigation lab for evaluation.The returned contents of the venaseal system included a dispensing gun; 1 ml syringe, blue introducer, and venaseal catheter.A visual inspection of the returned venaseal showed the plunger of the syringe was broken which connected to the dispensing gun.The dispensing gun was connected to the venaseal catheter, which was loaded in the introducer.Dried adhesive was noted at the distal tip of catheter and continued for approximately 0.4cm.A kink to the blue introducer was observed at the distal edge of the hub.A 3ml syringe from the lab was connected to the returned dispensing gun.The plunger was retracted completely and inserted the dispensing gun.It took 38 trigger pulls before plunger of the syringe advanced completely.On second testing round it took 39 trigger pulls, then on the 3rd attempt the plunger advanced after 39 trigger pulls.It should be noted, during each test the responsiveness of the gun was not consistent.The plunger would not move after some trigger pulls, but then advance during others.The dispensing gun was opened up for evaluation.The spacing of the friction grip measured at 0.0715".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.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction: this event was filed as ¿reportable malfunction¿ 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): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9934938
• MDR Text Key: 188118748
• Report Number: 9612164-2020-01508
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: VS-402
• Device Catalogue Number: VS-402
• Device Lot Number: 57291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 04/27/2020; 04/28/2020; 03/25/2021
• Supplement Dates FDA Received: 04/28/2020; 05/06/2020; 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 87619
• Patient Sequence Number: 1