MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC KIT 106CM 50CM TZ; CATHETER, CONTINUOUS FLUSH

Model Number	500-55150
Medical Device Problem Codes	Device Alarm System (1012); Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years of age or older.
Event or Problem Description
It was reported that during the use of an ekosonic deep vein thrombosis (dvt) catheter, displayed the device temperature too high alarm.The issue was able to be resolved through troubleshooting and therapy was restarted.Nine hours later, the temperature too high alarm occurred again.Troubleshooting was unsuccessful and ultrasound was turned off.No patient complications were reported.
Additional Manufacturer Narrative
Age at time of event: 18 years of age or older.Device evaluated by manufacturer: a visual examination identified blood in the drug lumens.Blistering on some of the elements in group 2, an indication of catheter use.The thermocouples aligned between the usc groups and a suture indention at 35.4 cm distal to the strain relief.The event log was also reviewed and showed the therapy was performed with a 50cm catheter.Temperature on thermocouple 3 (tc3) was above threshold and erratic at the beginning, which caused an "any_tc_hot" alarm and prevented ultrasound therapy from starting.The control unit power cycled, and the catheter was disconnected and reconnected.About 4.5 hours later, the ultrasound was able to start.This time tc3 was invalid and stayed invalid.A "temp_timeout" alarm occurred at 2.5 hours due to the tc3 issue and the alarm recurred 3 times between 7.7 to 9 hours, then was followed by a "temp_shutoff" and "any_tc_hot" alarms.The control unit was again powered cycled and the catheter disconnected and reconnected multiple times.Finally tc3 temperature settled at normal range and the therapy restarted and ran alarm free for 8 more hours.After the 50cm catheter disconnected, an 18cm catheter was connected and the therapy continued to run with no issues for 20 additional hours.The cu functioned as expected and no sign of rf drift was seen.In-house testing was able to replicate the issue.The readings on tc3 at 99.9 c and 100 c indicate a connection issue in the catheter.
Event or Problem Description
It was reported that during the use of an ekosonic deep vein thrombosis (dvt) catheter, displayed the device temperature too high alarm.The issue was able to be resolved through troubleshooting and therapy was restarted.Nine hours later, the temperature too high alarm occurred again.Troubleshooting was unsuccessful and ultrasound was turned off.No patient complications were reported.

• Brand Name: EKOSONIC KIT 106CM 50CM TZ
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s.; bothell WA 98011 8809
• MDR Report Key: 10142666
• Report Number: 2134265-2020-07660
• Device Sequence Number: 2561746
• 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: K182324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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: 01/15/2022
• Device Model Number: 500-55150
• Device Catalogue Number: 500-55150
• Device Lot Number: 0190206028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 08/19/2020
• Patient Sequence Number: 1