COOK VANDERGRIFT INC LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET; DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHERIZATION
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Catalog Number LR-EVN-13.0-RL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Low Blood Pressure/ Hypotension (1914)
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Event Date 03/05/2024 |
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.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.D2b ¿ product code: dre.G5 ¿ pma/510(k): 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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3x locking stylets, 4x one-ties, 1x bulldog were used.The 9fr shortie and 11fr evolution was advanced part way onto the ra lead, and the lead extracted.The physician noticed blood pressure dropping.
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