Device Problem
Insufficient Information (3190)
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Patient Problem
Cardiac Perforation (2513)
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Event Date 06/09/2014 |
Event Type
Injury
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Event Description
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During an electrophysiology procedure using a brk transseptal needle, a cardiac perforation occurred.A non-sjm catheter was advanced to the left atrium after a transseptal puncture with a brk transseptal needle and an unknown introducer.A cardiac perforation was noted via fluoroscopy and confirmed with an echocardiogram.A pericardiocentesis was performed and the patient was transferred to the operating room prior to removal of the catheter and introducer in case surgical intervention was required.Further information has been requested but is not yet available.
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Event Description
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During an atrial fibrillation ablation procedure using a brk transseptal needle, a cardiac perforation occurred.During transseptal puncture, the brk transseptal needle was inadvertently advanced into the aorta.The procedure was stopped and the patient was transferred to surgery to remove the needle.The needle was removed with no further intervention required and the patient recovered without issue.There were no performance issues with the needle.
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Manufacturer Narrative
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Additional information: the results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the batch number was unavailable.Based on the information received, the cause of the reported cardiac perforation was procedure related.Per the ifu, cardiac perforation is a known risk during the use of this device.
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Search Alerts/Recalls
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