Catalog Number LR-EVN-11.0-RL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Internal Organ Perforation (1987); Cardiac Perforation (2513)
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Event Date 11/23/2023 |
Event Type
Injury
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Manufacturer Narrative
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Blank fields on this form indicated the information is unknown, unchanged, or unavailable.G5 ¿ pma/510(k): k141148.The event is currently under investigation.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available or upon completion of investigation.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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Extraction.Hole in atrial appendage.Chest opened.2 stitches.Patient is fine.Cause of hole passive lead.Although the whole extraction kit was used, the passive lead caused the hole.The passive leads caused a hole in the atrial appendage.No equipment was at fault.Patient is fine and recovering.
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Manufacturer Narrative
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The device was not returned for the complaint; therefore, a physical investigation could not be performed, and the customer's complaint could not be confirmed, other than by the customer's testimony.The complaint/event that was entered and reported within trackwise: "during extraction passive leads caused small hole in the arterial appendage." this complaint mode is being monitored, tracked and trended per the cvi post market surveillance and complaint handling processes.A risk assessment will be performed and documented in the complaint summary tab in trackwise.G5 ¿ pma/510(k): k141148 this report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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Extraction.Hole in atrial appendage.Chest opened.2 stitches.Patient is fine.Cause of hole passive lead.Although the whole extraction kit was used, the passive lead caused the hole.The passive leads caused a hole in the atrial appendage.No equipment was at fault.Patient is fine and recovering.
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Search Alerts/Recalls
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