Product event summary: the 4fc12 sheath with lot 0011640164 was returned and analyzed.Visual inspection was performed, and a kink/twist was observed on the shaft, a kink was observed on the shaft inside handle, and a bent guide rod was observed.Additionally, the threaded slider-floater disk gap was out of spec.Visual inspection of the shaft area was performed and identified a shaft kink/twist at approximately 1.5 and 2 inches from the tip.Functional testing was performed, and the steering mechanism and deflection test revealed the noise was heard from the handle when the knob was turned with friction.Dissection of the returned device revealed a bent guide rod inside the handle which led to reflection difficulties.Dissection of the returned device revealed a gap between threaded slider and floater disk which caused a free rotate of the knob without turning the shaft.Dissection of the handle revealed a shaft torsion in the handle area.In conclusion, the sheath failed the returned product inspection due to a shaft kink/twist, a bent guide rod, and a threaded slider-floater disk gap.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, the atrial septal puncture site was too high causing the sheath to bend and the mapping catheter could not reach the right inferior pulmonary vein (ripv).As a result the sheath would bend excessively.The atrial septum was repunctured and the sheath was replaced to resolve the issue.Additionally, while advancing the balloon catheter a system notice was received indicating that the system did not recognize the catheter.The connections were reconnected without resolve.The mapping catheter cable was replaced without resolve.Another device was replaced without resolve.The balloon 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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