BOSTON SCIENTIFIC CORPORATION WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM; SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
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Model Number 10371 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)
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Event Date 08/24/2021 |
Event Type
Injury
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Event Description
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It was reported that perforation, pericardial effusion, and cardiac tamponade occurred.A left atrial appendage (laa) closure procedure was being performed.During placement of the watchman truseal access system (was) a 5f pigtail catheter was placed in the laa with difficulty during advancement over a stiff guidewire.The initial attempt at deployment of the 27mm watchman laa closure device was aborted because sheath placement was too proximal during unsheathing.The device was partially deployed with the feet of the device minimally exposed and was recaptured.An effusion sweep was performed and the sweep revealed a pericardial effusion.An angiogram was performed and perforation was noted.Initially, the patient's vital signs were stable but then became hypotensive.A pericardiocentesis was performed and the patient was taken to the operating room for surgical repair.There was suspicion that the difficult placement of the pigtail and stiff guidewire contributed to the perforation.Additionally, the tip of the was noted to have a tear.No additional information is known at this time.
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Event Description
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It was reported that perforation, pericardial effusion, and cardiac tamponade occurred.A left atrial appendage (laa) closure procedure was being performed.During placement of the watchman truseal access system (was) a 5f pigtail catheter was placed in the laa with difficulty during advancement over a stiff guidewire.The initial attempt at deployment of the 27mm watchman laa closure device was aborted because sheath placement was too proximal during unsheathing.The device was partially deployed with the feet of the device minimally exposed and was recaptured.An effusion sweep was performed and the sweep revealed a pericardial effusion.An angiogram was performed and perforation was noted.Initially, the patient's vital signs were stable but then became hypotensive.A pericardiocentesis was performed and the patient was taken to the operating room for surgical repair.There was suspicion that the difficult placement of the pigtail and stiff guidewire contributed to the perforation.Additionally, the tip of the was was noted to have a tear.No additional information is known at this time.It was further reported that the patient was out of bed the morning after surgery and recovered.
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