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

Catalog Number VS-402

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician used 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 that midway through the procedure the gun could no longer dispense glue.The procedure is reported to be partially completed.It is unknown if additional treatment was required.No patient injury reported.

Manufacturer Narrative

Product analysis: components (dispenser gun, catheter and one syringe) were returned for analysis.No damage noted on the gun.A 3ml syringer was inserted with the plunger pulled back during each functional test.Due to dried glue residue in the gun interior, the plunger was only able to be pulled back to 2.8 ml instead of 3 ml.The plunger failed to advance to the end of the syringe during three trigger tests, but after tightening the screws of the dispensing gun, the responsiveness of the trigger pulls was improved.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: 9472948
• MDR Text Key: 175237620
• Report Number: 9612164-2019-05182
• 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

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: VS-402
• Device Lot Number: 54696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 87619
• Patient Sequence Number: 1