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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As initially reported to customer relations: a 72-year-old male patient underwent a lead extraction with superior approach instruments procedure in which the lead extraction evolution rl controlled-rotation dilator sheath sets, g23746 and g23747, were used.3x locking stylets, 4x one-ties, 1x bulldog were used.The 11fr shortie with steady sheath and 11fr evolution with steady sheath were used to extract the ra lead, then 13fr evolution with steady sheath were advanced part way onto the rv lead.The physician noticed blood pressure dropping and proceeded with sternotomy.After patient was stable, the 13fr evolution and steady sheath were used to extract the rv lead, and 11fr evolution with steady sheath were used to extract the lv lead.
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