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

Catalog Number SP-101

Device Problems Defective Device (2588); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2021

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 bilateral great saphenous vein (gsv).The device was prepped as per ifu.A guidewire was used for insertion of the catheter.It is reported the gun was not dispensing consistent amount of venaseal.The j-tip wire discovered nearly broken after removed from patient following insertion of blue sheath with grey dilator.It was recommended to the physician to open a new venaseal kit to replace the gun and j-tip wire but the physician proceeded with the existing kit to treat the second leg.For access for treatment of the second limb the physician cut the j-tip that looks like going to fall off as it was unable to be passed through the blue introducer.After cutting the wire the physician decided to use the opposite end of the guidewire and access was smooth.The cut end of the guidewire did not enter patient body.Approximately 35cm of vein was treated.The vein is reported to have closed.No patient injury reported.

Manufacturer Narrative

Additional information: certain segments were still compressible when a last ultrasound check was done before case close.No resistance noted when removing the j-tip wire.No difficulty observed handling the guidewire.No section broke off in the patient.No additional treatment is required.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 review: two image files were returned for review.Image shows a j-wire guidewire with damage observed near the tip of the j-wire guidewire, part of the wire coiling was observed to be unraveled/extended but not detached consistent with the reported event.Image view of the outer carton.Product analysis: the venaseal device was returned to medtronic investigation lab for evaluation.The device was returned in tray in shelf carton box.Ancillary items were received.The dispenser gun, grey dilator, j-wire guidewire, partially used syringe with approximately 0.5ml present were returned for analysis.The j-wire guidewire was returned within the dilator and coiled within its outer sleeve.Inspection revealed no kinks on the returned ancillary items.The j-wire guidewire was removed from the dilator and from the coiled outer sleeve.Inspection revealed damage near the tip of the j-wire guidewire, part of the wire coiling was observed to be stretched/elongated but not detached.The j-wire guidewire was verified as.035¿ and 180cm in length.No damages or anomalies were observed to the exterior of the returned dispensing gun.The returned dispenser gun underwent functional testing.A 3ml monoject syringe from the lab was loaded into the dispensing gun.The plunger of the syringe was retraced to the 3ml mark of the barrel of the syringe.The trigger of the dispensing gun was pulled, and the plunger of the syringe did fully advanced to the distal end of the syringe barrel.This test was repeated twice.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 ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12757860
• MDR Text Key: 280610924
• Report Number: 9612164-2021-04233
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: SP-101
• Device Lot Number: 63893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2021
• Date Device Manufactured: 05/24/2021
• 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 Age: 61 YR
• Patient Sex: Female