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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 Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/29/2017
Event Type  malfunction  
Manufacturer Narrative
Patient identifier: (b)(6).
 
Event Description
(b)(6) study.It was reported that a catheter occlusion occurred.Patient was enrolled into the retrospective arm of (b)(6) and treated with the ekosonic device on (b)(6) 2017.One catheter placed through the right femoral vein into the right pulmonary artery.Approximately 5 hours into therapy, the infusion was stopped due to the catheter not infusing/clotting off.The ultrasound continued for about another 16 hours.The patient was scheduled to receive a total dose of 14mg through that catheter.No patient complications were reported.
 
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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 north creek pkwy south
bothell WA 98011
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10304754
MDR Text Key199857586
Report Number2134265-2020-09572
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
Reporter Country CodeUS
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 07/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2020
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 Received06/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age55 YR
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