Product event summary: the 990063-020 mapping catheter with lot unknown was returned and analyzed.Visual inspection was performed, and bond damage was observed at the shaft to the pebax tube fitting.Visual inspection of the loop segment area showed the loop was intact with no apparent issues.No damage was observed along with the tip/loop section of the mapping catheter.Visual inspection of the pebax segment area showed the pebax tubing at the shaft fitting joint was damaged.Visual inspection of the electrode(s) showed the electrode(s) were intact with no apparent issues.All electrodes exist on the loop section and no cosmetic issue or anomalies were identified.Visual inspection of shaft segment area showed the shaft was intact with no apparent issues.No kink or any other damage was observed along with the shaft of the mapping catheter.Visual inspection of the introducer showed the introducer/loop straightener was removed from the returned achieve mapping catheter and was not returned.Visual inspection of the lemo connector showed the lemo connector was intact with no apparent issues.No damage or any other issue was observed along with the lemo connector.In conclusion, the mapping catheter failed the returned product inspection due to a damaged pebax tubing bond.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.
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