Lot Number 0024692376 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombosis (2100)
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Event Date 02/07/2020 |
Event Type
Injury
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Event Description
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It was reported that a thrombus occurred.A left atrial appendage (laa) closure procedure was being performed.Pre-procedure transesophageal echocardiogram (tee) noted haziness in the laa, but no thrombus was observed.A watchman truseal access system (was) was inserted into the patient and another tee was performed upon approaching into the left atrium.At this time, a thrombus was seen in the laa.The case was aborted and all devices were removed.No thrombus was noted to the device itself.No further complications were reported.
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Manufacturer Narrative
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Returned product consisted of a watchman truseal system with the dilator snapped into the hub.Analysis of the tip, sheath, and hub/valve included microscopic and visual inspection.Inspection found no damage or defect to the device.The medical review for this device indicated that thrombosis was anticipated.
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Event Description
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It was reported that a thrombus occurred.A left atrial appendage (laa) closure procedure was being performed.Pre-procedure transesophageal echocardiogram (tee) noted haziness in the laa, but no thrombus was observed.A watchman truseal access system (was) was inserted into the patient and another tee was performed upon approaching into the left atrium.At this time, a thrombus was seen in the laa.The case was aborted and all devices were removed.No thrombus was noted to the device itself.No further complications were reported.
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Search Alerts/Recalls
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