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Model Number 4FC12 |
Device Problems
Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Stroke/CVA (1770)
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Event Date 12/28/2021 |
Event Type
Injury
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Event Description
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It was reported that after completing an ablation procedure with radiofrequency, the sheath was removed from the patient and damage was observed at the distal, deflection point.After the case, it was also reported that the patient experienced a stroke following a procedure.The patient¿s hospitalization was extended as a result of the stroke.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Product event summary: the 4fc12 sheath with lot 0010914679 was returned and analyzed.Visual inspection prior to disassembly and functional testing was performed on the shaft, handle, and dilator.The inspection of the shaft identified a shaft kink/twist at approximately 1.93 inches from the tip.The functional testing was performed.No anomaly was discovered.In conclusion, the clinical issue (stroke) occurred following the procedure.There is no indication of a relation of the adverse event to the performance or malfunction of the product.The sheath failed the returned product inspection due to a shaft kink and twist.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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Manufacturer Narrative
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Product event summary: data files were returned and analyzed.Patient files showed at least 22 applications were performed with balloon catheter afapro28 with lot 15148 without any issue on the date of the event.In conclusion, the clinical issue (stroke) occurred during the procedure.There is no indication of a relation to the adverse event to the performance and malfunction of the product.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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