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

Catalog Number VS-403

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Physician used a venaseal kit during treatment of patients great saphenous vein.Little vessel tortuosity is reported.The catheter lumen was not flushed prior to use.The ifu (instruction for use) was not followed, an 18g puncture needle and outer cannula were set in the syringe that absorb the glue and the glue was injected directly from the punctured site.The guidewire was not used during catheter insertion and placement.Tumescent infiltration was not utilized.Local anesthesia was used.No compression was used.12 segments were treated and vein is reported to have closed.The procedure was completed without any problems.After the treatment was completed, the glue was exposed outside the blood vessel from the puncture site to the skin and patient complained of pain and itching.After the surgery, the patient was on medication and wait-and-see approach was taken, but no improvement was observed, so the glue protruding on the skin was removed and the symptoms improved.

Manufacturer Narrative

Additional information: the patient had been continuously administered medication since the onset of celestamine symptoms which is standard procedure at this hospital.The glue was removed in a manner similar to a mass resection.The mass was removed to some depth as well as superficially.Issue is resolved.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.

Manufacturer Narrative

Image analysis film images were returned for review.Image 1: ¿image received of biologics on a cloth larger ¿pieces¿ of biologics appear to be roughly 1cm in height, not consistent with the reported event.Lot/batch number of the device/glue adhesive could not be confirmed based on the returned image.¿.Image 2: ¿image received of biologics on a cloth larger ¿pieces¿ of biologics appear to be roughly 1cm in height, not consistent with the reported event.Lot/batch number of the device/glue adhesive could not be confirmed based on the returned image.¿.Image 3: ¿image received of biologics on a cloth larger ¿pieces¿ of biologics appear to be roughly 1cm in height, not consistent with the reported event.Lot/batch number of the device/glue adhesive could not be confirmed based on the returned image.¿.Image 4: ¿image received of patient¿s leg with a ¿reaction¿/ ¿mass¿ apparent on the foot, consistent with the reported event.Lot/batch number of the device/glue adhesive could not be confirmed based on the returned image.¿.Image 5: ¿image received of patient¿s leg while undergoing a procedure, consistent with the reported event.Lot/batch number of the device/glue adhesive could not be confirmed based on the returned image.¿.Image 6: ¿image received of patient¿s leg seemingly post procedure with ¿mass¿ removed, consistent with the reported event.Lot/batch number of the device/glue adhesive could not be confirmed based on the returned image.¿.Image 7: ¿image received of patient¿s leg seemingly post procedure with ¿mass¿ removed but seemingly with a reaction, consistent with the reported event.Lot/batch number of the device/glue adhesive could not be confirmed based on the returned image.¿.Image 8: ¿image received of microscopical image under 2.5mm, not consistent with the reported event.Lot/batch number of the device/glue adhesive could not be confirmed based on the returned image.¿.Image 9: ¿image received of microscopical image under 500 ¿m, not consistent with the reported event.Lot/batch number of the device/glue adhesive could not be confirmed based on the returned image.¿.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: VENASEAL CLOSURE SYSTEM
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17315900
• MDR Text Key: 319023290
• Report Number: 9612164-2023-03159
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: VS-403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 07/13/2023; 09/13/2023
• Supplement Dates FDA Received: 08/02/2023; 09/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention