MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC KIT 106CM 40CM TZ; CATHETER, CONTINUOUS FLUSH

Device Problem Temperature Problem (3022)

Patient Problems Therapeutic Effects, Unexpected (2099); No Code Available (3191)

Event Date 08/13/2020

Event Type  Injury  

Event Description

It was reported that a second procedure was needed to replace the catheter.An ekosonic catheter was used to treat deep vein thrombosis (dvt) in the leg.A temperature alarm occurred and was able to be resolved through troubleshooting.The therapy ran for another 8 hours until the control unit alarmed again and ultrasound was discontinued.At this time, lytic therapy continued via the infusion pump.The next morning, patient was brought to the cath lab for follow up and the thrombus was found to still be present.Another ekos catheter was placed and therapy ran without issue for another 24 hour period.Additional intervention that was previously planned due to the patients chronic dvt was performed the following day.It was reported the case was successful with no patient complications.

Manufacturer Narrative

The complaint device was not returned by the customer; therefore, a product analysis could not be performed.An investigation was performed with the available information (product code, batch number, customer, as applicable) and efforts were taken to enable the determination of a probable cause.The complaint investigation conclusion code is: cause not established because the device and event log were not returned.The rep stated they were not given access to download the event log because the lab is not currently available.

Event Description

It was reported that a second procedure was needed to replace the catheter.An ekos catheter was used to treat deep vein thrombosis (dvt) in the leg.A temperature alarm occurred and was able to be resolved through troubleshooting.The therapy ran for another 8 hours until the control unit alarmed again and ultrasound was discontinued.At this time, lytic therapy continued via the infusion pump.The next morning, patient was brought to the cath lab for follow up and the thrombus was found to still be present.Another ekos catheter was placed and therapy ran without issue for another 24 hour period.Additional intervention that was previously planned due to the patients chronic dvt was performed the following day.It was reported the case was successful with no patient complications.

• Brand Name: EKOSONIC KIT 106CM 40CM TZ
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s.; bothell WA 98011
• MDR Report Key: 10482098
• MDR Text Key: 205282269
• Report Number: 2134265-2020-12105
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• PMA/PMN Number: K183361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

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?: No
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 10/06/2020
• Supplement Dates FDA Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention