Product event summary: the 990063-020 mapping catheter with lot number 223229096 was returned and analyzed.Visual inspection of the loop segment area showed the loop was kinked/twisted near the electrode#8.The user may have experienced insertion difficulties due to this issue when introducing the mapping catheter into the balloon catheter.The functional test was performed using a multimeter.The mapping catheter was connected to the test cable.The continuity and impedance measurement between electrodes and the other side of the cable showed the electrocardiogram (ecg) electrode #8 to pin 8 was an open circuit.Due to this issue the user may have experienced noise signal/lack of noise issue.The rest of the channels are normal.Dissection of the suspected electrode related to the noise revealed the electrode wire was detached from the welding at electrodes 8.In conclusion, the mapping catheter failed the returned product inspection due to the tip/loop kink.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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It was reported that during a cryo ablation procedure, after ablating the left upper pulmonary vein, the signal could not be displayed.The mapping catheter position was adjusted without resolve.The settings were correct.The mapping catheter cable was replaced without resolve.The cables were replaced without resolve.The mapping catheter was replaced to resolve the issue. the case was completed with cryo. no patient complications have been reported as a result of this event.
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