It was reported that during a cryo ablation procedure, when the mapping catheter was removed, it was noted on the mapping catheter tip that the metal was visible and the blue plastic was missing.The mapping catheter was replaced to resolve the issues.The case was completed with cryo.No patient complications have been reported as a result of this event.
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Product event summary: the 990063-020 mapping catheter with lot number 221278368 and images were returned and analyzed.The photos showed the tip of the mapping catheter was detached.The last photo showed the loop section was detached from the pebax shaft.One of the electrodes seemed to be missing.Visual inspection of the loop section of the mapping catheter showed the loop section of the mapping catheter was separated and returned.The mapping catheter shaft and body were not returned.The second electrode from the tip was missing.The array was broken off just before the electrodes.The pebax tubing on the tip of the mapping catheter was also ribbed out from the loop.In conclusion, the reported mapping catheter tip issue was confirmed through testing.The returned image confirmed the mapping catheter tip detached, broken loop section and missing electrode.The mapping catheter failed the returned product inspection due to a detached loop section and pebax tubing at the tip, and a missing electrode.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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