Model Number 8115 |
Device Problems
Human-Device Interface Problem (2949); Material Integrity Problem (2978)
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Patient Problems
Syncope (1610); Death (1802); Cardiac Tamponade (2226); Vascular Dissection (3160); Pericardial Effusion (3271)
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Event Date 08/01/2018 |
Event Type
Death
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Manufacturer Narrative
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The catheter was not expected to be returned.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
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Event Description
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Boston scientific received information that while trying to access the coronary sinus with this catheter, a dissection occurred.The patient was syncopal and their blood pressure was very low.The physician identified a pericardial effusion and a preicardiocentesis was performed.The patient was intubated and stabilized.Only the right ventricular lead and device were implanted; no left ventricular lead was tried.No additional adverse patient effects were reported.
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Event Description
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Boston scientific received information that while trying to access the coronary sinus with this catheter, a dissection occurred.The patient was syncopal and their blood pressure was very low.The physician identified a pericardial effusion and a pericardiocentesis was performed.The patient was intubated and stabilized.Only the right ventricular lead and device were implanted; no left ventricular lead was tried.No additional adverse patient effects were reported.Boston scientific received additional information about this case.It was reported the physician had performed another pericardiocentesis later in the evening on the date of the implant procedure, but the patient subsequently died due to a cardiac tamponade.It was noted the physician had experienced some difficulty finding the coronary sinus and after the cs cannulation, there was some resistance introducing the delivery system.The implanted products were not explanted post-mortem.
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Search Alerts/Recalls
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