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Model Number 4FC12 |
Device Problems
Peeled/Delaminated (1454); Compatibility Problem (2960)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/02/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Product event summary: the 4fc12 with lot number 0011835141 was returned and analyzed.Visual inspection before functional testing and dissection was performed on the shaft, handle, and dilator.No anomaly was identified during the external visual inspection the handle, shaft and sideport were intact with no apparent issue.Functional testing was performed.Insertion of the dilator into the sheath was performed and the dilator luer was unable to be locked to the sheath.Further inspection under the microscope identified dilator luer damage.Delamination was observed at the dilator luer polyethylene.In conclusion, the reported dilator/sheath compatibility issue was confirmed through testing and the sheath failed the returned product inspection due to dilator luer damage/delamination at the dilator luer polyethylene.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 prior to a cryo ablation procedure, the dilator could not be fixed to the sheath due to extra plastic on the hub.The sheath was replaced which resolved 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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H6: device codes (fdd/annex a): a040506 is no longer relevant due to the delamination at the dilator luer polyethylene was removed from the product analysis.Us supplemental reg rep: corrected h11: the product analysis was corrected.Delamination at the dilator luer polyethylene was removed from the product analysis.Therefore, this incident is no longer reportable.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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