MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number	500-55130
Medical Device Problem Code	Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Common Device Name: EKOSONIC ENDOVASCULAR CATHETER
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• MDR Report Key: 9696617
• Report Number: 3001627457-2020-00005
• Device Sequence Number: 1810536
• Product Code: KRA
• UDI-Device Identifier: 00858593006165
• UDI-Public: 00858593006165
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K182324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 500-55130
• Device Catalogue Number: 500-55130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1