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

Model Number VS-404

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/24/2021

Event Type  malfunction  

Event Description

Physician used a venaseal kit during treatment of the patient's great saphenous vein (gsv).Ifu was followed.It is reported the delivery catheter broke off from the cap/white tip where it screws on to the syringe.Detachment occurred during treatment.Unknown if detachment happened away from patient.Detachment happened while treating when pulling catheter back after an aliquot. all components are accounted for.A second kit was opened to complete the procedure.35cm of vein was treated.The vein is reported to have closed.No additional treatment was required.No patient injury reported.

Manufacturer Narrative

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

Manufacturer Narrative

Product analysis: the venaseal ancillary components were returned to medtronic investigation lab for evaluation.The device was returned in biohazard bag within safe pack pouch.No cines or images of the procedure were included.The venaseal ancillary components returned for analysis consisted of a dispenser gun, and the white catheter within in a clear biohazard bag.When the catheter were removed from the packaging, it was the observed that the white catheter was detached from its spin lock/port hub from the white catheter, the spin lock/port hub was not returned for evaluation.Polymerized adhesive was evident along the returned catheter shaft.Visual inspection of the detached portion of the catheter revealed the tear was most likely longitudinal.No abnormalities or deformities were noted with the returned dispenser gun.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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 12983000
• MDR Text Key: 282111896
• Report Number: 9612164-2021-04812
• Device Sequence Number: 1
• Product Code: PJQ
• UDI-Device Identifier: 00763000240776
• UDI-Public: 00763000240776
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: VS-404
• Device Catalogue Number: VS-404
• Device Lot Number: 61310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2020
• 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