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Model Number 10FCC20 |
Device Problems
Gas/Air Leak (2946); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/14/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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It was reported that during a pulsed field ablation procedure, the side port of the sheath had a kink in it.The sidearm of the sheath was against the patient, and while aspiration was being performed, microbubbles were observed in the sidearm.Despite the issues, case was completed with pulsed field ablation. 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: image files and the 10fcc20 sheath with lot number 0012103835 were returned and analyzed.Two photos were received and both photos showed microbubbles observed in the side port tube of the sheath.Visual inspection of the sheath was performed and identified a kink at the side port tube.The tip of the sheath was intact with no anomaly.The functional testing was performed and no anomaly was discovered.The lab test dilator was inserted into the sheath and retracted several times, without any friction.The lab test dilator was snap-locked to the sheath and was tight.Visual inspection and magnifying with a high-resolution microscope showed the valve housing was intact without any issue.The performance test with sentinel blackbelt leak tester was performed.The pressure test with 45 pounds per square inch gauge (psig) showed the pressure decay in the device was 0.069 psig and in an acceptable range.The vacuum test with a negative pressure of 8.5 psig showed the pressure decay in the device was 0.013 psig and in an acceptable range.In conclusion, the microbubbles were observed in the images but air ingress was not reproduced during analysis.The side port kink was confirmed during the analysis and the sheath failed the returned product inspection due to a kink on the side port tube.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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