Model Number 18-3356 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Cardiac Perforation (2513)
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Event Date 01/27/2022 |
Event Type
Injury
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Event Description
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During a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation, blood pressure became unstable while ablating the right inferior pulmonary vein after ablation of the left-sided veins.Order of vein treatment was left superior, left inferior, right inferior, and right superior.After ablation of the right superior pulmonary vein it was determined cardiac tamponade had occurred.Cardiac drainage was immediately performed but additional treatment was required including surgical repair.The perforation site was identified as the tip of the left atrial appendage.Approximately one week post procedure the patient was showing signs of improvement.
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Manufacturer Narrative
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No device deficiency reported.Cardiac tamponade is a known potential adverse event of catheter ablation procedures disclosed in product labeling.It was reported the tip of the ablation catheter was completely inside the sheath while the sheath was manipulated in the left atrium.This is contrary to product labeling in which the soft tip of the catheter is recommended to be extended from the sheath during sheath movement.It cannot be determined if this deviation from the instructions from use contributed to this adverse event.The cause of the perforation was not determined, but the sheath cannot be excluded as a cause.
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Manufacturer Narrative
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No device deficiency reported.Cardiac tamponade is a known potential adverse event of catheter ablation procedures disclosed in product labeling.It was reported the tip of the ablation catheter was completely inside the sheath while the sheath was manipulated in the left atrium.This is contrary to product labeling in which the soft tip of the catheter is recommended to be extended from the sheath during sheath movement.It cannot be determined if this deviation from the instructions from use contributed to this adverse event.The cause of the perforation was not determined, but the sheath cannot be excluded as a cause.
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Event Description
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During a pulmonary vein isolation (pvi) procedure to treat atrial fibrillation, blood pressure became unstable while ablating the right inferior pulmonary vein after ablation of the left-sided veins.Order of vein treatment was left superior, left inferior, right inferior, and right superior.After ablation of the right superior pulmonary vein it was determined cardiac tamponade had occurred.Cardiac drainage was immediately performed but additional treatment was required including surgical repair.The perforation site was identified as the tip of the left atrial appendage.Approximately one week post procedure the patient was showing signs of improvement.
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Search Alerts/Recalls
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