MAUDE Adverse Event Report: BTG BOTHELL EKOSONIC KIT 106CM 50CM TZ; CATHETER, CONTINUOUS FLUSH

Model Number 500-55150

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 11/10/2020

Event Type  Injury  

Event Description

It was reported that a catheter leaking from hub occurred from coolant port.An ekosonic catheter was selected for use to treat deep vein thrombus (dvt).At approximately 3 hours of therapy run time, the nurse noticed the pillow under the patent's foot was wet and a leak was noted from the hub of the coolant port.The nurse was unsure if she had permission to flush.The patient was taken back to the cath lab and a new ekos catheter was placed.The therapy was completed successfully with good patient outcome.No patient consequences were reported.

Manufacturer Narrative

Product investigation was completed.Leaking from the hub was observed.Blood was noted in both the coolant and drug lumens.A crack was found at the microsonic device (msd) luer on the hub.The damage on the luer appears to be induced by use error.

Event Description

It was reported that a catheter leaking from hub occurred from coolant port.An ekosonic catheter was selected for use to treat deep vein thrombus (dvt.At approximately 3 hours of therapy run time, the nurse noticed the pillow under the patent's foot was wet and a leak was noted from the hub of the coolant port.The nurse was unsure if she had permission to flush.The patient was taken back to the cath lab and a new ekos catheter was placed.The therapy was completed successfully with good patient outcome.No patient consequences were reported.

• Brand Name: EKOSONIC KIT 106CM 50CM TZ
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BTG BOTHELL; 11911 north creek parkway s.; bothell WA 98011 8809
• MDR Report Key: 10938804
• MDR Text Key: 219295464
• Report Number: 2134265-2020-16768
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500-55150
• Device Catalogue Number: 500-55150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Date Manufacturer Received: 01/21/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention