|
Device Problem
Biocompatibility (2886)
|
Patient Problems
Fever (1858); Local Reaction (2035); Burning Sensation (2146)
|
Event Date 12/17/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Physician used the venaseal closure system to treat the great saphenous vein(gsv).Local anaesthesia was used.The vessel had minimal tortuosity.There was reflux.The gsv was found to be run outside the fascia, however there was a lot of subcutaneous fat and the tortuosity was weak due to deep running.Ifu was followed and a guidewire was used for insertion of the catheter.Catheter tip 5cm caudal to saphenofemoral junction during delivery.The short axis was compressed by the probe.The vein is reported to have closed.The procedure was completed normally.It was reported that there was local reddening and heat sensation 9 days post procedure.The patient's body temperature had a slight fever at 37 degree level.Patient status with health hazard.Loxoprofen prescribed by doctor.No update on patient condition, as patient has not returned for follow up.
|
|
Manufacturer Narrative
|
Additional information: the patient will not return for follow up unless presenting with symptoms.There is currently no plans for follow up.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.
|
|
Search Alerts/Recalls
|
|
|