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Device Problem
Difficult to Insert (1316)
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Patient Problem
Cardiac Perforation (2513)
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Event Date 03/14/2024 |
Event Type
Injury
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Event Description
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During an implantation procedure, a cardiac tamponade occurred which required a pericardiocentesis to stabilize the patient.The transseptal puncture was performed using the transseptal sheath and needle, no wire, and was reported to be difficult, requiring several attempts to puncture the septum.The implant was completed successfully but approximately 45 minutes post-procedure, the patient experienced hypotension.Transthoracic echocardiography was performed and a pericardial effusion was observed which resulted in a cardiac tamponade.A pericardiocentesis was performed, 500 ml of blood was drained, and the patient stabilized.In the physician's opinion, the pericardial effusion was due to the difficult transseptal puncture requiring multiple manipulations.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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During an implantation procedure, a cardiac tamponade occurred which required a pericardiocentesis to stabilize the patient.The transseptal puncture was performed using the transseptal sheath and needle, no wire, and was reported to be difficult, requiring several attempts to puncture the septum.The implant was completed successfully but approximately 45 minutes post-procedure, the patient experienced hypotension.Transthoracic echocardiography was performed and a pericardial effusion was observed which resulted in a circumferential cardiac tamponade.A pericardiocentesis was performed, 500 ml of blood was drained, and the patient stabilized.In the physician's opinion, the pericardial effusion was due to the difficult transseptal puncture requiring multiple manipulations.There were no reported performance issues with any abbott device.
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Search Alerts/Recalls
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