The device and event log were returned.The event log from the case confirmed the reported all msd disabled alarm at 16.9 hours into therapy due to the phase angle for the ultrasound groups going above the operational threshold.The control unit functioned as expected.The device investigation on january 30th showed blistering over the transducer elements.Tool mark was observed on msd at 3.2 cm.The in-house cu would immediately alarm when trying to run the msd.Investigation into the msd hub revealed all wires were shorted and fluid was observed inside hub.The route of fluid ingress into the hub is undetermined.During manufacturing, msd are 100% tested and a short would be detected during the final impedance test.Therefore, it is likely that fluid ingress occurred during use.The device short was not reported by the user, but could contribute to the reported all msd disabled alarm.Review of the device history record confirmed that the product was manufactured per standard processes and met all acceptance criteria.There have been no other reported complaints from msds of the same lot.No patient harm was reported.No definitive root cause could be identified.The ifu warns the user to not advance if resistance is met.Excessive force against resistance may result in damage to the device or vasculature.User error was not confirmed but could not be ruled out as a contributing factor to the msd short.
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On (b)(6) 2020, 17 hours into therapy, icu nurse called with an all msd groups disabled alarm.The catheter was used to treat a peripheral arterial occlusion (pao).She mentioned that the black cable may have been kinked when the control unit (cu) alarmed, but that it was then straightened out.Troubleshooting performed did not clear the alarm.The nurse was instructed to notify the doctor that the catheter would now run as a basic infusion catheter.The patient was "doing great".On 30 january 2020, investigation of the returned device revealed that the microsonic device (msd) shorted due to fluid ingress into the hub after 17 hours of therapy.This was not reported by the customer.
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