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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802); Complaint, Ill-Defined (2331); Blood Loss (2597); No Code Available (3191)
Event Date 04/09/2020
Event Type  Death  
Manufacturer Narrative
Graif, assaf, et al.Evaluation of fibrinogen levels during catheter-directed thrombolysis for acute pulmonary embolism.Journal of vascular and interventional radiology, vol.31, no.8, 2020, pp.1281-1289., doi:10.1016/j.Jvir.2020.04.032.Date of death and event date are unknown; therefore, they are estimated.
 
Event Description
It was reported via journal article that patient complications occurred.A retrospective review was performed to evaluate the effect of catheter-directed thrombolysis with tissue plasminogen activator (tpa) on plasma fibrinogen levels in patients with acute pulmonary embolism.The ekosonic endovascular system catheter was a device referenced within the study.Major bleeding, cardiac arrest, thrombocytopenia, and procedure related death were noted to have occurred.No further information is known at this time.This report will be updated should additional information become available.
 
Manufacturer Narrative
Correction to h6: patient code.Graif, assaf, et al.Evaluation of fibrinogen levels during catheter-directed thrombolysis for acute pulmonary embolism.Journal of vascular and interventional radiology, vol.31, no.8, 2020, pp.1281-1289., doi:10.1016/j.Jvir.2020.04.032.Date of death and event date are unknown; therefore, they are estimated.
 
Event Description
It was reported via journal article that patient complications occurred.A retrospective review was performed to evaluate the effect of catheter-directed thrombolysis with tissue plasminogen activator (tpa) on plasma fibrinogen levels in patients with acute pulmonary embolism.The ekosonic endovascular system catheter was a device referenced within the study.Major bleeding, cardiac arrest, thrombocytopenia, and procedure related death were noted to have occurred.No further information is known at this time.This report will be updated should additional information become available.
 
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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 Key10683000
MDR Text Key211446504
Report Number2134265-2020-14172
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,litera
Type of Report Initial,Followup
Report Date 11/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received11/04/2020
Patient Sequence Number1
Patient Outcome(s) Death; Required Intervention;
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