MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC KIT 135CM 50CM TZ; CATHETER, CONTINUOUS FLUSH

Model Number 500-56150

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 11/04/2020

Event Type  Injury  

Manufacturer Narrative

Age at time of event: over 18 years of age.The reported batch/lot (200218011-004).

Event Description

It was reported that a leak occurred from the intelligent drug delivery catheter (iddc) port requiring additional procedure for replacement.An ekosonic catheter was selected for use during a deep vein thrombosis (dvt) procedure.At approximately 1-2 hour of therapy run time, a leak was noted on the drug lumen.At this time, ultrasound was paused.Troubleshooting steps taken and did not resolve the leak.The patient was taken back to the cath lab and a new ekos catheter was placed.The therapy was completed successfully.No patient consequences were reported.

Manufacturer Narrative

The catheter came back for analysis.No damage was observed on the drug luer, the coolant luer, or the manifold luer.A kink mark was observed 83.0 cm distal to the strain relief and another kink was noted under the strain relief.Fluid was not seen emitting from the luers when either the drug and coolant lines were flushed.Further, no bubbles were seen when the device was flushed under water.No damage or issues were noted with the ultrasound core (usc).A potential source of the leak could have been a mal-fitted connection to the drug luer during therapy.Age at time of event: over 18 years of age.

Event Description

It was reported that a leak occurred from the intelligent drug delivery catheter (iddc) port requiring additional procedure for replacement.An ekosonic catheter was selected for use during a deep vein thrombosis (dvt) procedure.At approximately 1-2 hour of therapy run time, a leak was noted on the drug lumen.At this time, ultrasound was paused.Troubleshooting steps taken and did not resolve the leak.The patient was taken back to the cath lab and a new ekos catheter was placed.The therapy was completed successfully.No patient consequences were reported.

• Brand Name: EKOSONIC KIT 135CM 50CM TZ
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s.; bothell WA 98011
• MDR Report Key: 10905915
• MDR Text Key: 218496466
• Report Number: 2134265-2020-16457
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• PMA/PMN Number: K182324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/21/2021

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
• Device Expiration Date: 01/19/2023
• Device Model Number: 500-56150
• Device Catalogue Number: 500-56150
• Device Lot Number: 200218011-004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention