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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); Pain (1994); Cardiac Tamponade (2226); Pericardial Effusion (3271)
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Event Date 04/10/2023 |
Event Type
Injury
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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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Event Description
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It was reported that during a cryo ablation procedure, after the replacement of the sheath and balloon catheter self test, the patient blood pressure was measured and was found to be hypotensive.The patient was noted to be in pain.Cardiac tamponade and pericardial effusion were confirmed.The pericardial effusion drainage was performed.The procedure was aborted.The patient was not under general anesthesia.The patient hospitalization was extended; the patient was observed for 3 days after drainage of the pericardial effusion and then was discharged.The patient was later referred for a cardiac ultrasound examination. 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 0010892924 and data files were returned and analyzed.There were no failure files or power up test files received, and the returned patient files was corrupted and could not be assessed.The reported clinical issues cannot be assessed through data analysis.Visual inspection was performed on the sheath, and no anomaly was identified during the external visual inspection.The handle, shaft and sideport were intact with no apparent issue.The functional testing was performed, and no anomaly was discovered.The performance test with a leak tester was performed.The sheath passed the test, and the pressure decay in the device was 0.054 psig and in the acceptable range (should be less than 0.945 psig).The shaft and valve are leak-tight with no apparent issue.In conclusion, the reported clinical issues occurred during the procedure.The sheath passed the returned product inspection per specification.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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