MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number	500-56112
Medical Device Problem Codes	Fracture (1260); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event log shows the therapy was run with a 12cm catheter (sn (b)(4)) for about 10 hours starting on (b)(6) 2018.After 9.7 hours of therapy, on (b)(6) 2018, phase angle for both msd groups went above threshold 35 degree causing no_groups_enabled alarm and the alarm persisted.The event log confirmed that the control unit functioned as intended.The device was returned for evaluation.During the investigation on 13 nov 2018, damage was noted to both the msd and the iddc.The msd treatment zone showed normal signs of use.The msd tubing was pulled apart at 8.7cm leaving one of the braided stainless steel wires and one natural colored rf wire holding the two pieces of tubing together.Damage to the iddc included tc wires doubled over within the drug lumens, kink in the stiffening wire and in the tubing, and broken tc wires at the distal end of the strain relief.The broken tc wires lined up with the area of the msd tubing that had been pulled apart.There was no evidence of shorted wires or other burn marks in the msd or iddc.The damage on the msd corresponds to the damaged area of the iddc which suggests the devices were connected (msd inserted in iddc) when the damage occurred.The msd is not inserted in the iddc during the manufacturing process; therefore, it is likely that the damage/fracture occurred during handling/use.A 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.The reported patient non-compliance could not be ruled out as a cause or contributing factor to the msd and iddc damage.No patient harm was reported.
Event or Problem Description
It was reported that a patient with a right upper arm extremity dvt was treated with ekos on (b)(6) 2018.During therapy, alarm code 'all msd failure' occurred.Ekos was discontinued and treatment was continued as standard cdt (catheter directed thrombolysis).The patient was reported as being noncompliant with the instructions/advice of the staff and physician.The patient was getting up, walking around the room, sitting up bedside and "thrashing arm about" during therapy.The patient did receive the full dose of therapy and is doing very well.The device was returned 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: 8153567
• Report Number: 3001627457-2018-00035
• Device Sequence Number: 11310284
• Product Code: KRA
• UDI-Device Identifier: 00858593006264
• UDI-Public: 00858593006264
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2018

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: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 500-56112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1