The device was discarded by the customer and, therefore, a physical investigation could not be performed to determine the exact root cause.The site did not provide the serial number, so a review of the device history record could not be performed.While no patient impact or adverse event was reported, the patient underwent thrombectomy procedure to remove the remaining clot.
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On 8 september 2019, the icu nurse called ekos helpline with a dso alarm on the coolant port.The catheter was being placed to treat dvt.Ekos representative went over troubleshooting steps but was not able to resolve the issue.Ekos representative advised the nurse to reach out to physician and have them pull back on the catheter to clear a possible obstruction and if the physician did not feel comfortable then they would have to run as a standard infusion catheter.The patient was reported as doing good.On 10 september 2019, additional information was received that the customer was unable to clear the dso alarm and the catheter was used as an infusion catheter.The catheter was not saved.Patient was taken back to the catherization lab for a thrombectomy procedure on (b)(6) 2019 to remove the remaining clot.There were no other patient sequelae reported.
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