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Model Number 4FC12 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Twitching (2172); Cardiac Tamponade (2226); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/12/2023 |
Event Type
Injury
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Event Description
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It was reported that during a cryo ablation procedure, the patient became agitated and 'unconscious behavior' increased.Under fluoroscopy, the heartbeat was observed to be weakened.It was judged that the patient had a pericardial tamponade so a pericardial puncture and drainage was performed.After drainage, the patient's blood pressure and oxygen returned to normal.The case was aborted and the patient was hospitalized. no further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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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.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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Manufacturer Narrative
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Updated b5 event description added h6 patient codes.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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Patient was hypotensive prior to blood pressure returning to normal.
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Event Description
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It was later reported that the "unconscious behavior" manifested as twitching of limbs and the patient wanting to sit up, but the patient still had no relevant consciousness.Patient was hypotensive prior to blood pressure returning to normal.
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Manufacturer Narrative
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Product event summary: the 4fc12 sheath with lot 0011603826 was returned and analyzed.Visual inspection was performed, and a leak was observed at the hemostasis valve.During the external visual inspection, no anomaly was identified.All the handle, shaft and sideport were intact with no apparent issue.The steering mechanism and deflection test were performed.The shaft was bending as initially intended and was bending in the plane.There is no difficulty, no friction, or any noise in the steering mechanism.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 issue.The performance test with a leak tester was performed.The pressure test with 30 psig showed the pressure decay in the device was 0.019 psig (should be lower or equal to 0.3 psig).The flushing test with 6 psig showed the pressure decay in the device was 0.005 psig (should be lower or equal to 0.2 psig).The aspiration test with negative pressure of 4.1 psig showed the pressure decay in the device was below pressure psig (should be lower or equal to 0.2 psig).The performance test failed.Dissection and pressure testi ng of the returned device revealed a leakage at the hemostasis valve; the valve disk was suspected to be torn.In conclusion, the reported clinical issues (cardiac tamponade, agitation, aborted under general anesthesia, hypotension) were not confirmed through product analysis.The sheath failed the returned product inspection due to a hemostasis valve leak.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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2023-06-06: it was later reported that the "unconscious behavior" manifested as twitching of limbs and the patient wanting to sit up, but the patient still had no relevant consciousness.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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