Model Number PSCC100 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/04/2024 |
Event Type
malfunction
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Event Description
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It was reported that during a pulsed field ablation procedure, the guidewire was unable to be retracted into the catheter and the j-tip became looped around the array.The issue was visibly observed on fluoroscopy.The catheter was moved to the left side which resolved the issue.Upon removal, a piece of tissue was observed between the array and the wire.The capture tool was "roughly" pulled back, the array was submerged under water, the capture tool was placed over the array again, and the catheter was reinserted into the patient.It was then reported that the slide button was unable to be pushed to retract the array.Several attempts were performed unsuccessfully.The catheter was rotated while the array was pulled back slowly which resolved the issue. the 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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Continuation of d10: product id: unknown non-medtronic, product type: guidewire.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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