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Model Number 4FC12 |
Device Problems
Compatibility Problem (2960); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 09/06/2023 |
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, the dilator would not snap into the sheath.The sheath was not replaced as it was judged to be fixed tightly into the dilator.While the sheath was in the left atrium what was thought to be a potential clot was seen on the imaging.The potential clot was not seen prior to the transeptal access.It could not be determined if the object seen was an actual clot.The patient was stable and showed no signs of stroke or st-elevation.The case continued.The potential clot was not seen during the rest of the procedure.The case was completed with cryo.The patient hospitalization was not extended.No further patient complications have been reported as a result of this event.
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Event Description
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It was reported that during a cryo ablation procedure, the dilator would not snap into the sheath.The sheath was not replaced as it was judged to be fixed tightly into the dilator.While the sheath was in the left atrium what was thought to be a potential clot was seen on the imaging.The potential clot was not seen prior to the transeptal access.It could not be determined if the object seen was an actual clot.The patient was stable and showed no signs of stroke or st-elevation.The case continued.The potential clot was not seen during the rest of the procedure.The case was completed with cryo.The patient hospitalization was not 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: data files and the 4fc12 sheath with lot number 0011835143 were recieved and analyzed.The patient data file showed 21 applications were performed using a catheter identified as afapro28 with lot 9977.The patient data file didn't show any system notice on the reported date of the event.The received failure file did not contain any failure records for the date of the event.Visual inspectionof the sheath before functional testing and dissection was performed on the shaft, handle, and dilator.No anomaly was identified during the external visual inspection.All the handle, shaft and sideport were intact with no apparent issue.The insertion of dilator into the sheath was performed.Unable to lock the dilator luer to the sheath.Further inspection under microscope identified a dilator luer damage.In conclusion, the reported "clot" issue occurred during the procedure and could not be confirmed through analysis.The sheath/dilator compatibility issue was confirmed through analysis and the sheath failed the returned product inspection due to the dilator luer damage and preventing it to lock with the sheath handle.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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