It was reported that an unknown patient underwent an ventricular tachycardia (vt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that a patient suffered cardiac tamponade during.At the end of the vt case, ultrasound was used to check for effusion, which increased slightly, resulting in drainage.The drainage was placed, and the patient was returned to the icu.It was unknown when the complication occurred, there was no abnormal appearance, and there was a comment that it was not caused by bw product.The physician commented that it was unknown when the complication occurred, there was no abnormal appearance, and there was a comment that it was not caused by bw product.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.
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On 28-dec-2021, bwi received additional information regarding the event.This adverse event was discovered post use of biosense webster products.The physician¿s opinion on the cause of this adverse event is unknown.Intervention provided: drainage was performed.Generator information: smartablate.Prior to noting the ct ablation was performed.There was no evidence of steam pop.No error messages were observed on biosense webster equipment during the procedure.Additionally, the product investigation has been completed as the complaint device was not returned.Device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30633777l number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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