MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Catalog Number	500-55150
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to ekos and evaluated on 10 jan 2018.Evaluation of the returned msd revealed evidence of shorted wires.The iddc was in used condition but no damage was observed.Evaluation conclusion - the root cause of the shorted wires was not identified.A review of the device history record for the msd confirmed that the product was manufactured per standard processes and met all acceptance criteria.No patient impact was reported.The damage did not affect the iddc and therefore did not come into contact with the patient's vasculature.The event did not impact the delivery of thrombolytic therapy.No serious injury occurred as a result of this malfunction.The control unit event log recorded that ultrasound was delivered for a total of 24.9 hours.
Event or Problem Description
On (b)(6) 2017, a helpline call reported a temperature alarm after 16 hours and 40 minutes of therapy.The alarm was resolved over the phone with the ekos representative by increase the coolant rate through the device.The device was returned to ekos for evaluation.

• 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: 7254802
• Report Number: 3001627457-2018-00004
• Device Sequence Number: 16170707
• Product Code: KRA
• UDI-Device Identifier: 00858593006189
• UDI-Public: 00858593006189
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2018

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: 07/09/2020
• Device Catalogue Number: 500-55150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1