It was reported that after a successful a cryo ablation procedure, the balloon catheter was unable to be pulled back into the sheath.The catheters were removed from the patient, and the sheath and the guide wire lumen of the balloon catheter were kinked.No patient complications have been reported as a result of this event.
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Product event summary: an image of the 4fc12 sheath with unknown lot number was returned and analyzed.The returned image showed the shaft of the sheath was ribbed at the distal end before the tip, when the balloon catheter was inserted into the sheath.In conclusion, the reported damaged sheath shaft was confirmed through the returned photograph.The sheath failed the returned product inspection due to shaft damage.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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