Model Number PSCC100 |
Device Problems
Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Loss of Vision (2139); Embolism/Embolus (4438); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/19/2024 |
Event Type
Injury
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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 (pfa) procedure, fluoroscopy image showed that the array of the pfa catheter was inverted.The guidewire was pulled into the catheter and the slider was moved forward in order to try to move the array back to its shape.Additionally, noise from electrodes 1-2 was shown un the electrophysiology (ep) recording system.The catheter was not repla ced. the case was completed with pulsed field ablation.After removal of the catheter from the body, some damage was detected on the plastic between electrodes 1-2.It appeared to be kinked.No patient complications have been reported as a result of this event.
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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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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 later reported that no medical or surgical intervention was carried out but the patient's hospitalization was extended.The patient has not yet recovered from the embolism and vision issue.
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Event Description
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Additional information was received indicating that after the procedure and before discharge, the patient complained about an eye problem.The patient list their vision partially.Medical tests were performed.It was concluded that the patient suffered an embolism that affected the retinal vein.The patient was discharged.No further patient complications have been reported as a result of this event.
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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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Search Alerts/Recalls
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