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

Model Number 500-56150

Device Problems Break (1069); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2021

Event Type  Injury  

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 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
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s.; bothell WA 98011
• Manufacturer (Section G): EKOS CORP INC; 11911 n. creek parkway s.; bothell WA 98011
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11686352
• MDR Text Key: 246054806
• Report Number: 2134265-2021-04987
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: 00858593006318
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention