MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number UNKNOWN

Device Problems Occlusion Within Device (1423); Device Handling Problem (3265)

Patient Problems Therapeutic Response, Decreased (2271); Radiation Exposure, Unintended (3164)

Event Date 11/09/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation and no lot number was reported.It was reported that the coolant was turned off in the pacu while the ultrasound and tpa were left running.The ifu warns the user to never transmit ultrasound energy to infusion catheter or ultrasonic core unless it is placed within the patient anatomy, physician-specified fluids are running through the drug lumen and coolant is flowing through the coolant lumen.The user error of turning off the coolant likely caused the occlusion, while the user error of aspirating the coolant line likely exacerbated the occlusion.The ifu instructs the user that if flow through the infusion catheter becomes restricted, either remove the infusion catheter (and ultrasonic core, if in place) to determine and eliminate the cause of the obstruction or replace the infusion catheter with a new infusion catheter of the same model.The required medical intervention including additional exposure to x-ray and a new catheter placement was due to user error and not a result of a device malfunction.

Event Description

It was reported on (b)(6) 2017 through a helpline call from an icu nurse that during ekos treatment of a unilateral (left) dvt, the patient was received in the icu from the pacu with the ultrasound running but no coolant running.The therapy running time was 7 hours and 12 minutes at the time of the helpline call.The caller was unsure of how long the ultrasound was running with no coolant, but no alarms had occurred.The ultrasound was stopped at the direction of the helpline.It was reported that the caller attempted to flush the coolant line but was unsuccessful.The caller then aspirated the coolant line.The helpline explained that aspirating any infusion lines of the ekos catheter would only make the occlusion worse.Trouble shooting was unsuccessful and the physician was notified that the ultrasound was turned off, the coolant line was occluded, but the tpa could continue to run as a normal infusion catheter.Follow up information was received from the physician that he ballooned the clot before placing the ekos catheter.The physician reported that the coolant was started in the ir lab but somehow it was turned off by someone in the pacu.The physician reported that without ultrasound, he believes not much clearance was achieved.This patient was brought back to the ir lab for placement of a new ekos catheter.It was reported that after the catheter exchange, the second therapy was successful with excellent clearance of the clot and the patient outcome was reported as "very good".The first catheter was discarded and will not be returned for evaluation.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• Manufacturer (Section G): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• Manufacturer Contact: sandra bausback ; 300 barr harbor dr.; five tower bridge - suite 810; west conshohocken, PA 19428-2998 ; 6103311537
• MDR Report Key: 7075508
• MDR Text Key: 93488192
• Report Number: 3001627457-2017-00033
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention