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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC®; CATHETER, CONTINUOUS FLUSH
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EKOS CORPORATION EKOSONIC®; CATHETER, CONTINUOUS FLUSH Back to Search Results
Model Number 6795-002
Device Problem Device Inoperable (1663)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/24/2017
Event Type  malfunction  
Event Description
An ekos catheter was used during a pe lysis and was reported by staff to be faulty.This catheter was removed from the field and a new catheter was introduced.The same issue occurred with the second catheter.After the second catheter was removed from service, a different type of lysis catheter was introduced and worked properly.No harm came to the patient.Manufacturer will send a representative to pick up the device and handle its return/failure analysis.
 
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Brand Name
EKOSONIC®
Type of Device
CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
EKOS CORPORATION
11911 n. creek pkwy south
bothell WA 98011
MDR Report Key6507110
MDR Text Key73255732
Report Number6507110
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 User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/12/2017,04/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date12/19/2020
Device Model Number6795-002
Device Catalogue Number500-56112
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/12/2017
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer04/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age50 YR
Patient Weight150
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