The results of the investigation are inconclusive since the device was not returned for analysis. additionally, a review of the device history record was not possible as a lot number was not provided.Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.
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Related manufacturing ref: 3005334138-2019-00440, 2182269-2019-00112, 3005334138-2019-00441, 2030404-2019-00071, 2182269-2019-00114, 2182269-2019-00115, 2030404-2019-00072.During a left lateral accessory pathway ablation, a pericardial effusion occurred.One hour following transseptal access, the patient became hypotensive when ablating the pathway.Intracardiac ultrasound revealed a large effusion.A pericardiocentesis was performed to stabilize the patient.There were no performance issues with any abbott device.
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