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

Catalog Number SP-101

Device Problems Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)

Patient Problems Occlusion (1984); Obstruction/Occlusion (2422)

Event Date 11/02/2020

Event Type  Injury  

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 the great saphenous vein (gsv).The lumen was flushed prior to use.Ifu was followed.It was reported that when guidewire approached to the junction and the blue introducer was inserted, physician tried to pull out the guidewire and it was stuck to the dilator.Physician pulled it very hard, dilator broke.Due to vessel spasm, physician had to use laser to treat varicose vein.Physician mentioned that it is the first time the guidewire was stuck.When physician checked that the dilator broke, is now worried that any part of components may be in the vein.The physician checked several times with ultrasound.The patient ifs fine and has no symptoms, so physician used laser to finish the procedure.There was no patient injury reported.

Manufacturer Narrative

Device evaluation: visual inspection: the device was removed from the return packaging for evaluation.The grey introducer and guidewire were returned loaded through the blue introducer blue introducer: an area of damage was observed on the blue introducer, near the white hub.The introducer appeared twisted and compressed (photo 5).The damage was 0.2cm in length the length of the introducer was approximately 80.1cm, consistent with specification microscopic inspection: a tear was observed along the twisted portion of the dilator.The observed damage is consistent with excess force being applied to remove the guidewire and introducer no anomalies, such as tearing was noted at the distal tip of the introducer grey dilator: the grey dilator was attempted to be removed; however, only the proximal portion of the dilator was able to be removed.The dilator was unable to be fully removed.Inspection of the proximal portion of the dilator revealed twisting near the hub.Stretching of the dilator was also observed, consistent with excessive force to remove the dilator.The length of damage was approximately 1.5cm microscopic inspection: a dried clear/white substance was observed along the portion of the dilator that was able to removed from the introducer.The material is consistent with contrast or dried adhesive a dried blood-like substance was also observed along the grey introducer guidewire: the guidewire was then attempted to be removed from the dilator.The guidewire was able to be successfully removed.A dried white material, consistent with dried adhesive and/or contrast was noted along the guidewire a bend was found along the guidewire approximately 33.0cm proximal to the guidewire distal tip microscopic inspection: material appears consistent with dried adhesive or contrast no anomalies were noted at the distal tip of the guidewire.No fracturing or detachment was observed clear catheter: clear adhesive was observed inside the catheter.A bend was seen in the catheter approximately 83.4cm proximal to the catheter¿s distal tip 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: 10828079
• MDR Text Key: 215885590
• Report Number: 9612164-2020-04390
• 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: 03/02/2021

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: 08/27/2021
• Device Catalogue Number: SP-101
• Device Lot Number: 56741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 02/26/2021
• Supplement Dates FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 55