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Model Number 4FC12 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226)
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Event Date 01/30/2024 |
Event Type
Injury
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Manufacturer Narrative
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Product id 2af283 ; product type: balloon catheter product id 990063-020; product type: mapping catheter 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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Event Description
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It was reported that during a cryo ablation procedure, after the transeptal puncture, when the upper pulmonary vein (pv) was frozen, the mapping catheter penetrated the pericardium.Imaging of the pericardium showed that a cardiac tamponade was present in the peri cardium.The patient became hypotensive.The patient's bleeding could not be stopped after emergency treatment, therefore a thoracotomy was performed.The case was aborted.The patient was not under general anesthesia.The patient's hospitalization was extended. no further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the 4fc12 sheath with lot number 0012012422 was returned and analyzed.The original dilator was not received with the sheath.Visual inspection before functional testing and dissection was performed on the shaft, handle, and dilator.No anomalies were identified during the external visual inspection.The handle, shaft, and side port were intact with no apparent issues.Functional testing was performed and no anomalies were discovered.The dilator was inserted into the sheath and retracted several times, without any friction.The dilator was snap-locked to the sheath and was tight.Visual inspection and magnifying with a high-resolution microscope showed the dilator luer and tip were intact without any issues.The sheath test with the lab dilator passed.In conclusion, the clinical issues of cardiac tamponade, perforation, hypotension, bleeding occurred during the procedure with no indication that the adverse event was related to the performance or a malfunction of the product and the sheath passed the returned product inspection.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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