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U.S. Department of Health and Human Services

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

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EKOS CORPORATION EKOSONIC KIT 135CM 50CM TZ; CATHETER, CONTINUOUS FLUSH Back to Search Results
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.
 
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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 Key11686352
MDR Text Key246054806
Report Number2134265-2021-04987
Device Sequence Number1
Product Code KRA
UDI-Device Identifier00858593006318
UDI-Public00858593006318
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183361
Number of Events Reported1
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 Date06/15/2023
Device Model Number500-56150
Device Catalogue Number500-56150
Device Lot Number0010790333
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/23/2021
Initial Date FDA Received04/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/15/2020
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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