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Model Number FA-55160-1030 |
Device Problem
Break (1069)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This event was received as medwatch (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received a report that the marksman catheter tip sheared during procedure.The issue was noticed after angiogram and thrombectomy when the catheter was removed.The broken portion was removed intact with no patient complications.
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Event Description
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Additional information received indicated that the devices were prepared per the ifu, the patient's vessel tortuosity was moderate, and the patient did not experience any symptoms as a result of the event.No further intervention was taken as the marker pieces unraveled but were still intact in the catheter.The cause of the event remains unknown.Ancillary devices include 6f shuttle jet 7, synchro guidewire.
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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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Manufacturer Narrative
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B5.Product analysis findings: the marksman total length was measured to be ~169.0cm and the useable length was measured to be ~161.5cm which is within specification (specification: 160cm ± 3cm).No damages or irregularities were found with the marksman hub.The marksman catheter body was fond kinked at ~23.0cm, 18.0cm, and 7.5cm from the distal end.The distal ~5.5cm of the marksman catheter body was found flattened.The marksman distal marker was found dislodged from the catheter tip.The dislodged marksman marker band was not returned.The separated outer tubing material exhibited with plastic deformation (jagged edges and stretching).There does not appear to be any separation of the inner liner.The inner wire was found stretched out from between the inner and outer tubing.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿catheter separation/break¿ was confirmed.The separated outer tubing material exhibited with plastic deformation which indicates the marker band dis lodged as the tensile strength of the tubing material was exceeded.The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary.Based on the formal investigation conducted possible causes for the event could be attributed to patient¿s highly tortuous anatomy and/or other contributing factors such as kink/damage in guide catheter / balloon guide catheter /guidewire/stents which may have contributed to resistance during delivery and/or retrieval, subsequently causing the marksman catheter to become damaged.For the marker band to dislodge from the catheter the distal shaft needs to be damaged and/or separated from the catheter, which is unlikely to occur without experiencing excessive resistance.In addition, hard clots /calcifications in the navigation tract can snag the catheter, this may be detected under fluoroscopic use of the product and as instructed in the ifu, without observing the resultant tip response, the catheter shouldn¿t be attempted to move further.As the marksman was found flattened it is likely that the guide catheter was kinked/damaged causing the marksman to flatten if pulled through, likely against resistance, subsequently causing the marker to dislodge.H6.Coding updated based on analysis results.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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