BOSTON SCIENTIFIC CORPORATION WATCHMAN FXD CURVE ACCESS SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
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Model Number TU-8002 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 12/16/2022 |
Event Type
Injury
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Event Description
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It was reported that thrombosis occurred.A left atrial appendage (laa) closure procedure was performed using a 27mm watchman flx laa closure device with delivery system (wds) and watchman fxd curve access system (was).Following the transeptal puncture, 10,000 units of heparin were administered.The closure device was positioned and deployed.After deployment of the closure device a thrombus was identified on the outer distal tip of the was sheath.Heparin was again administered.Several unsuccessful attempts were made to aspirate the thrombus into the was before the was was withdrawn to the right atrium.Once the was was in the right atrium the thrombus was no longer visible.The patient will undergo physician monitoring for potential adverse effects related to the thrombus.
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Manufacturer Narrative
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B5 event description updated.
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Event Description
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It was reported that thrombosis occurred.A left atrial appendage (laa) closure procedure was performed using a 27mm watchman flx laa closure device with delivery system (wds) and watchman fxd curve access system (was).Following the transeptal puncture, 10,000 units of heparin were administered.The closure device was positioned and deployed.After deployment of the closure device a thrombus was identified on the outer distal tip of the was sheath.Heparin was again administered.Several unsuccessful attempts were made to aspirate the thrombus into the was before the was was withdrawn to the right atrium.Once the was was in the right atrium the thrombus was no longer visible.The patient will undergo physician monitoring for potential adverse effects related to the thrombus.It was further reported that patient was prescribed an anticoagulant and no adverse events have occurred.
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