Correction: the lot number for this device is unknown.Additional information: initially, the customer reported clots formed on the catheter.Additional information provided on 15-aug-2018 from the customer stated the clots were seen via ultrasound along the outside of the device.The device was removed, the patient was given aspirin and a week later the clots were absent during a follow-up echocardiograph.The device did not malfunction nor have potential to cause of contribute to patient harm.This incident does not meet the criteria for a reportable event.Event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury or product malfunction as the device did not malfunction nor have potential to cause or contribute to patient harm.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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