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Model Number 10373 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)
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Event Date 02/27/2019 |
Event Type
Injury
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Event Description
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It was reported that a pericardial effusion occurred.A watchman access system (was) double curve was selected for use during a left atrial appendage (laa) closure procedure.After the was and unknown pigtail catheter were positioned, contrast was injected and a pericardial effusion and perforation were noted.At this time, the implanting physician selected a watchman laa closure device and delivery system and deployed the closure device while a second physician simultaneously performed a pericardiocentesis.Approximately 100ccs of blood was drained.Patient had a small decrease in blood pressure without signs of tamponade.After the device was released the was withdrawn to the right atrium and protamine was given.At the end of the case, patient was taken to the intensive care unit.The patient was discharged the next morning post-implant without issues.Upon review of the videos, implanter noted the tip of the pigtail appeared to be in a small pocket with the pigtail portion not fully out of the was.It is likely that the pigtail also pushed forward during advancing the was in the laa causing the perforation.
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Event Description
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It was reported that a pericardial effusion occurred.A watchman access system (was) double curve was selected for use during a left atrial appendage (laa) closure procedure.After the was and unknown pigtail catheter were positioned, contrast was injected and a pericardial effusion and perforation were noted.At this time, the implanting physician selected a watchman laa closure device and delivery system and deployed the closure device while a second physician simultaneously performed a pericardiocentesis.Approximately 100ccs of blood was drained.Patient had a small decrease in blood pressure without signs of tamponade.After the device was released the was was withdrawn to the right atrium and protamine was given.At the end of the case, patient was taken to the intensive care unit.The patient was discharged the next morning post-implant without issues.Upon review of the videos, implanter noted the tip of the pigtail appeared to be in a small pocket with the pigtail portion not fully out of the was.It is likely that the pigtail also pushed forward during advancing the was in the laa causing the perforation.It was further reported that the pigtail catheter was a 5 fr bsc pigtail.
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Manufacturer Narrative
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Correction made to field with updated device information.
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Search Alerts/Recalls
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