MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number	500-56140
Medical Device Problem Code	Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The msd and iddc were returned for investigation.Msd was received neatly coiled with the cable cut off and not returned.Kinks evident in the treatment zone.On (b)(6) 2019, the investigation found kinks in the msd treatment zone and kinks and twisting in the msd shaft.At 2.6cm from the strain relief the msd shaft was kinked, heat shrink was broken which could allow fluid inside the shaft, and the rf wires had shorted.The short is likely due to damage and fluid ingress when being placed in the patient.It should be noted that the patient was not directly exposed to the damaged shaft, coolant would flow over this section into the patient.The electrical short in the msd did not affect the iddc and therefore did not come into contact with the patient's vasculature.Review of the manufacturing records confirmed the catheter was manufactured according to existing specifications; therefore, the damage observed on the received device is likely the result of use/handling that occurred outside of ekos.No patient impact or adverse event was reported.
Event or Problem Description
On (b)(6) 2019, after 4 hours therapy, icu nurse called with all msd groups disabled alarm.Prior to calling she had tried rebooting the control unit and checking connections.Ekos rep went over troubleshooting steps and tried rebooting the machine again.The alarm persisted.The rep recommended to inform the physician that the ultrasound was turned off and the catheter was running as a standard infusion catheter.The patient was reported to be doing great.On (b)(6) 2019, investigation found that the msd cable had shorted, likely due to damage and fluid ingress when being placed in the patient.While no patient impact or adverse event was reported, serious injury could occur if this malfunction was to recur.

• 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: 8827399
• Report Number: 3001627457-2019-00020
• Device Sequence Number: 226294
• Product Code: KRA
• UDI-Device Identifier: 00858593006172
• UDI-Public: 00858593006172
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/05/2019

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: 02/28/2021
• Device Model Number: 500-56140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2019
• Initial Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1