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

Catalog Number SP-101

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2019

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 venaseal occluding device to treat 45 cm in the great saphenous vein (gsv).Ifu was followed during preparation, procedure and post-procedure.A guide wire was used for the insertion of the catheter.It was reported that during procedure, the gun did not deliver the adhesive during one of the triggering, causing one segment of the vein not sealing off properly.Physician only noted after sealing off the next 2 segments and the catheter could not be reinserted or readvanced.The procedure was completed as per ifu.Physician then applied longer pressure on the non-sealed segment (after next few segments) in hope that the drops of adhesive from the previous and after segments might contact with more blood and help to seal off the empty segment.There was no patient injury reported.

Manufacturer Narrative

Product analysis: the venaseal dispenser gun was received for evaluation.The catheter was returned with a syringe attached.Visual inspection of the dispenser gun revealed no abnormalities or deformities.In other to replicate the reported event, a known good 3ml syringe from analysis lab was attached to the dispenser gun.The gun was advance successfully to the syringe tip after 36 trigger pull.The test was replicated three additional times with no resistance encountered.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: transducer and hand compression were applied to the non-sealed segment.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: 8897019
• MDR Text Key: 154428790
• Report Number: 9612164-2019-03435
• 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
• 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: 02/28/2021
• Device Catalogue Number: SP-101
• Device Lot Number: 54619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 08/21/2019; 10/23/2019; 03/25/2021
• Supplement Dates FDA Received: 08/26/2019; 10/29/2019; 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 87619
• Patient Sequence Number: 1
• Patient Age: 63 YR