MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number	500-55140
Medical Device Problem Codes	Fracture (1260); Electrical Shorting (2926)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ekosonic msd was returned with the cable cut off, the msd treatment zone was returned in three segments (the iddc was not returned).The device evaluation revealed 2 fractures in the msd treatment zone.The proximal section was observed to have blistering at the core of the treatment zone in the sub-groups between the elements indicating use.The medial section was observed to be sheared off at the proximal end and the distal end had signs of being shorted.The distal section showed signs of being kinked at the core wire and rf wires being bent over at the fracture location, but no signs of wear on this section.The distal tip of the treatment zone is bent and the wires between the sub-groups are wavy.The core wire in the distal fracture had a severe bend indicating that it was most likely kinked.The catheter ran therapy for approximately one hour before the cu started to display msd alarms.It appears that the kink likely caused damage to the insulation of the rf wire which, after prolonged application of rf power, initiated a short.Based on the evaluation, the proximal break appears to have sheared off and most likely occurred during the removal of the msd catheter.The fracture zones were inspected for evidence of manufacturing defects and none were noted.The fractured msd was recovered from the patient without causing patient harm.The ifu warns the user to not advance if resistance is met without first determining the cause of resistance under fluoroscopy and taking any necessary remedial action.Excessive force against resistance may result in damage to the device or vasculature.User error was not confirmed, but could not be ruled out as a cause or contributing factor to the msd fracture.
Event or Problem Description
It was reported that the msd fractured inside a patient during ekos treatment of a deep vein thrombosis (dvt) on (b)(6) 2018.It was reported that there was no issue with placement or advancing the catheter.It was reported that another 40 cm catheter was placed with no issues which ran successfully for approximately 19 hours of therapy.The final patient outcome was good.The patient was not harmed as a result of the fractured msd.Upon investigation of the returned device, the reported complaint was confirmed by device damage.

• 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: 7377667
• Report Number: 3001627457-2018-00010
• Device Sequence Number: 1636548
• Product Code: KRA
• UDI-Device Identifier: 00858593006172
• UDI-Public: 00858593006172
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Hospital Service Technician
• Type of Report: Initial
• Report Date (Section B): 03/07/2018

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: 06/30/2018
• Device Model Number: 500-55140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1