MAUDE Adverse Event Report: EKOSONIC ENDOVASCULAR CATHETER EKOSONIC ENDOVASCULAR CATHETER

Model Number	500-56140
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned for investigation.The event log showed the therapy on (b)(6) 2019 was performed with a 40cm catheter (sn (b)(4)) for 1.8 hours and no alarms were noted.Right before the case end, temperature for group 2 through group 5 went above 43°c and up to 45°c intermittently, but did not cause any alarms.Then the stop button was pressed and the case ended.The control unit functioned as intended and did not have issues.The returned device was investigated on 3/14/2019.The ekosonic kit was returned with the msd advanced in the iddc coolant lumen, blood in the drug and coolant lumens.One transducer element showed signs of heat exposed to blood within the drug lumen.However, no manufacturing defects were observed with the device.The device was ran on an in-house control unit for 1.9 hours with no alarms and no temperature readings above 43 c during ultrasound delivery.The ekosonic ifu provides a warning that during normal use, ultrasound energy may cause a temperature rise in the treatment zone.The catheter surface temperature is limited to a maximum of 43° c.Pain is an anticipated harm associated with the use of the device, contained within the risk documents and listed in the product ifu as a potential adverse event.Review of the device history record indicated that the product was manufactured according to specifications and met all acceptance criteria prior to release.
Event or Problem Description
On (b)(6) 2019, a physician contacted ekos informing that he performed a venous case and found the patient to be in excruciating pain after placement of ekos catheter.The pain was from the access site in the popliteal all the way up the patient leg.He reported that the patient's motor function in the leg had gotten worse while the catheter was in the patient.The physician decided to remove the catheter.He turned the us off and removed the catheter and found it to be extremely hot but nobody sustained any burns.After removal, the patient's pain went from a "9" down to a "3".Treatment was discontinued and no further action was needed or executed.There were no patient sequala reported.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Common Device Name: EKOSONIC ENDOVASCULAR CATHETER
• Manufacturer (Section D): EKOSONIC ENDOVASCULAR CATHETER; 11911 north creek parkway s; bothell WA 98011 8809
• MDR Report Key: 8478008
• Report Number: 3001627457-2019-00013
• Device Sequence Number: 1846979
• Product Code: KRA
• UDI-Device Identifier: 00858593006301
• UDI-Public: 00858593006301
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 500-56140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other