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.If information is provided in the future, a supplemental report will be issued.
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A physician used venaseal closure system to treat the great saphenous vein (gsv) of a patient.No tumescent infiltration utilized.Local anesthesia was used.A guidewire used for the insertion of the catheter.The lumen was flushed prior to use.The ifu was followed during preparation, procedure, post-procedure.The vein closed.Th patient reported to the physician that that experienced mycolicibacterium fortuitum in their leg after the procedure.Infection became apparent 2-4 weeks after treatment.It had a vague onset starting 2-3weeks.Mild redness and tenderness.Did not think it was a hypersensitivity reaction.It became worse at about a month.Patient followed up with doctors in their hometown and we lost contact with them as they would not communicate with us.Patient was hospitalized and sounds like pretty sick for a time.It sounded like a surgeon removed the distal aspect of the vein and glue near the access site but i have no definite record of this.The infection is not thought to be chronic - treatment provided was surgery and antibiotics - no further patient injury reported for this event.
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