MAUDE Adverse Event Report: EKOS CORPORATION; CATHETER, CONTINUOUS FLUSH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 10/01/2020

Event Type  Death  

Manufacturer Narrative

Date of event is unknown: therefore, date is estimated.

Event Description

It was reported that a death occurred.An ekosonic catheter was selected for use during a deep vein thrombosis (dvt) procedure.An unknown time post-procedure, patient passed away.Cause of death is unknown at this time.No device issues were reported.No further information is currently known.This report will be updated should additional information become available.

• 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 Key: 10764108
• MDR Text Key: 213935257
• Report Number: 2134265-2020-14986
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death