Model Number 00884450265604 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Patient Problem/Medical Problem (2688); Pericardial Effusion (3271)
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Event Date 05/05/2020 |
Event Type
Injury
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Manufacturer Narrative
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The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
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Event Description
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The account alleges that during a left atrial appendage closure [laac] procedure, a pericardial effusion occurred.The physician had successfully acquired access to the patients left atrium via transseptal puncture.A closure device was introduced into the left atrium -a couple of times- needing recapture due to a 5 mm gap that was appreciated.A 33 mm closure device was successfully deployed within the posterior lobe when a pericardial effusion was noted.A full recapture of the closure device was completed.The patient was in stable condition, so a new 33 mm closure device was implanted in the upper lobe.After first release of the second device, good positioning was observed.Eventually the patient's vital signs changed indicating that cardiac massage and pericardiocentesis was necessary.The patient was transferred in stable condition to surgery.
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Manufacturer Narrative
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The suspect device was returned for evaluation.The device was examined visually, and functional testing was performed.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exception documents were found.
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Search Alerts/Recalls
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