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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC KIT 106CM 12CM TZ; CATHETER, CONTINUOUS FLUSH
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EKOS CORPORATION EKOSONIC KIT 106CM 12CM TZ; CATHETER, CONTINUOUS FLUSH Back to Search Results
Device Problems Device Alarm System (1012); Difficult to Flush (1251); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/25/2020
Event Type  malfunction  
Event Description
It was reported that a downstream occlusion alarm on the drug line occurred.An ekosonic catheter was selected for use during a bilateral pulmonary embolism (pe) procedure.Approximately 8 hours into the procedure, drug line was leaking on the stopcock.The nurse tightened it but a downstream occlusion occurred to the drug pump.At this time, the line was flushed three times with a 3 cc syringe but was unsuccessful.Ultrasound was turned off at this time and the procedure was completed unilaterally.The patient outcome was reported as positive.No patient consequences were reported.
 
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Brand Name
EKOSONIC KIT 106CM 12CM TZ
Type of Device
CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
EKOS CORPORATION
11911 north creek parkway s.
bothell WA 98011
Manufacturer (Section G)
EKOS CORPORATION
11911 n. creek parkway s.
bothell WA 98011
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10705538
MDR Text Key212132531
Report Number2134265-2020-14409
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182324
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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