MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC KIT 135CM 12CM TZ; CATHETER, CONTINUOUS FLUSH

Model Number	500-56112
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a leak occurred and an error message displayed.An ekosonic catheter was selected for use in a unilateral pulmonary embolism procedure.During the procedure, a significant fluid leak occurred at the hub of the device.Additionally, the control unit displayed an e322 alarm indicating all thermocouples invalid.At this time, treatment had been running over 29 hours.The physician turned off the coolant to see if the fluid leak was saline or thrombolytic (tpa).The leak was confirmed to be tpa as the leak continued after the saline coolant was turned off.The physician stated the catheter would be removed.No patient complications were reported.

• Brand Name: EKOSONIC KIT 135CM 12CM TZ
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s.; bothell WA 98011
• MDR Report Key: 12212088
• Report Number: 2134265-2021-09436
• Device Sequence Number: 3210222
• Product Code: KRA
• UDI-Device Identifier: 00858593006264
• UDI-Public: 00858593006264
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K182324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2021

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: 12/14/2023
• Device Model Number: 500-56112
• Device Catalogue Number: 500-56112
• Device Lot Number: 0011809926
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 07/22/2021
• Patient Sequence Number: 1