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H3: evaluation summary: one device was received for evaluation.The visual inspection found sensor damage.The tpe is damaged, the sensor is damaged where the tpe damage occurred.The tpe damage allowed reprocessing fluid to be introduced into the catheter, resulting in corrosion.The customer reported that the catheter doesn¿t calibrate.The reported condition was confirmed.The investigation found sensor #9 is unstable.There is an intermittent break every 6th sensor.All impedance sensors have signal and are functional in saline solution.The pico scope data shows sensors #9 is unstable.The investigation found the most probable cause to be the sensor damage.The probable root cause was found to be user mishandling.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.
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