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Model Number 4FC12 |
Device Problems
Fluid/Blood Leak (1250); Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/12/2023 |
Event Type
malfunction
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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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Event Description
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It was reported that during a cryo ablation procedure, when inserting the balloon catheter into the sheath, the air bubbles were unable to be cleared out of the sheath.The consumables were removed from the patient and the sheath replaced to resolve the issue. the case was completed with cryo. no 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 0011672894 was returned and analyzed.Visual inspection was performed, and a bond leak was observed at shaft to hemostasis valve assembly fitting.During the external visual inspection, no anomaly was identified.All the handle, shaft and sideport were intact with no apparent issue.The performance test with leak tester was performed.The pressure test with 30 psig showed the pressure decay in the device was sever leak psig (should be lower or equal to 0.3 psig).The flushing test with 6 psig showed the pressure decay in the device was sever leak 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 sever leak psig (should be lower or equal to 0.2 psig).The performance test failed.Dissection and pressure testing of the returned device revealed a leakage at the bond between the shaft and valve assembly.In conclusion, the sheath failed the returned product inspection due to a shaft to hemostasis valve bond 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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Search Alerts/Recalls
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