MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number	500-55150
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The msd was not returned for evaluation.Without the msd being evaluated, the reported smoke coming from the msd upon removal from the patient cannot be confirmed.The ultrasound was reported to be running while the msd was being removed from the patient.Based on this information, the visible "smoke" noted by the users was likely liquid evaporation caused by the heat from the msd which would resemble visible smoke.The ifu instructs the user to discontinue the ultrasound prior to removal of the device.No patient impact or injury was reported in association with this event.If additional information is received, a follow up report will be submitted.
Event or Problem Description
During complaint follow up communication, it was reported that upon final removal of the msd, there was visible smoke.It was reported that the ultrasound was still on while the msd was being removed from the patient.There was no patient impact or injury reported in association with the visible smoke.The msd was discarded by the user.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• MDR Report Key: 7522415
• Report Number: 3001627457-2018-00018
• Device Sequence Number: 19192068
• Product Code: KRA
• UDI-Device Identifier: 00858593006189
• UDI-Public: 00858593006189
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2018

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: Physician
• Device Expiration Date: 12/30/2020
• Device Model Number: 500-55150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1