MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC KIT 135CM 50CM TZ; CATHETER, CONTINUOUS FLUSH

Model Number	500-56150
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The all msd groups disabled alert was confirmed through event log and device analysis.The evidence of the rf drift on the control unit (cu) likely accelerated wear on the ultra sonic core (usc).The char seen on the usc points to a short and failure of one of the transducer elements in the usc.It appears the shorting in the usc may have contributed to the failure and eventual fracture of the device.
Event or Problem Description
It was reported that an ultrasonic core fracture occurred.An ekosonic catheter was selected for use during a deep vein thrombosis procedure.During the procedure an all msd groups disabled alarm occurred.The alarm was unable to be resolved; therefore, the procedure was completed by running the catheter as a standard infusion catheter.Upon recheck the following day, it was discovered that the ultrasonic core wire had broke inside the patient.The catheter was successfully snared out with a non-bsd snare.No patient complications were reported.

• Brand Name: EKOSONIC KIT 135CM 50CM TZ
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s.; bothell WA 98011
• MDR Report Key: 11686352
• Report Number: 2134265-2021-04987
• Device Sequence Number: 19615114
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: 00858593006318
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K183361
• 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): 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/15/2023
• Device Model Number: 500-56150
• Device Catalogue Number: 500-56150
• Device Lot Number: 0010790333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/19/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention