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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EKOS CORPORATION; CATHETER, CONTINUOUS FLUSH
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EKOS CORPORATION; CATHETER, CONTINUOUS FLUSH Back to Search Results
Device Problems Device Alarm System (1012); Obstruction of Flow (2423)
Patient Problems No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/03/2020
Event Type  Injury  
Manufacturer Narrative
Reported lot number: 200210089-004.
 
Event Description
It was reported that a drug occlusion resulting in catheter replacement occurred.An ekosonic catheter was selected for use.At the start of therapy, a down stream occlusion alarm occurred to the drug infusion pump.Multiple troubleshooting steps were performed per the instructions for use without resolution.It was then decided to bring the patient back to the catheterization lab for replacement of the catheter.After catheter exchanged, a drug infusion alarm was still occurring to the drug pump, for which they swapped the pump and reset the pump pressure settings.The procedure was successfully completed without further consequences.No patient injury was reported.
 
Event Description
It was reported that a drug occlusion resulting in catheter replacement occurred.An ekosonic catheter was selected for use.At the start of therapy, a down stream occlusion alarm occurred to the drug infusion pump.Multiple troubleshooting steps were performed per the instructions for use without resolution.It was then decided to bring the patient back to the catheterization lab for replacement of the catheter.After catheter exchanged, a drug infusion alarm was still occurring to the drug pump, for which they swapped the pump and reset the pump pressure settings.The procedure was successfully completed without further consequences.No patient injury was reported.
 
Manufacturer Narrative
Catheter was returned for investigation.The obstruction was caused when the catheter was aspirated causing blood to move up into the drug holes to the drug lumen.The ifu states clearly to not aspirate the catheter as it will clog the perfusion pores and cause a downstream occlusion alarm.Reported lot number: 200210089-004.
 
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Type of Device
CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
EKOS CORPORATION
11911 north creek parkway s.
bothell WA 98011
MDR Report Key11040271
MDR Text Key222630484
Report Number2134265-2020-17918
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/12/2021
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2021
Initial Date Manufacturer Received 12/03/2020
Initial Date FDA Received12/18/2020
Supplement Dates Manufacturer Received01/22/2021
Supplement Dates FDA Received02/12/2021
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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