MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number UNKNOWN

Device Problem Audible Prompt/Feedback Problem (4020)

Patient Problem Thrombus (2101)

Event Date 09/08/2019

Event Type  Injury  

Manufacturer Narrative

The device was discarded by the customer and, therefore, a physical investigation could not be performed to determine the exact root cause.The site did not provide the serial number, so a review of the device history record could not be performed.While no patient impact or adverse event was reported, the patient underwent thrombectomy procedure to remove the remaining clot.

Event Description

On 8 september 2019, the icu nurse called ekos helpline with a dso alarm on the coolant port.The catheter was being placed to treat dvt.Ekos representative went over troubleshooting steps but was not able to resolve the issue.Ekos representative advised the nurse to reach out to physician and have them pull back on the catheter to clear a possible obstruction and if the physician did not feel comfortable then they would have to run as a standard infusion catheter.The patient was reported as doing good.On 10 september 2019, additional information was received that the customer was unable to clear the dso alarm and the catheter was used as an infusion catheter.The catheter was not saved.Patient was taken back to the catherization lab for a thrombectomy procedure on (b)(6) 2019 to remove the remaining clot.There were no other patient sequelae reported.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Type of Device: EKOSONIC ENDOVASCULAR CATHETER
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• Manufacturer (Section G): EKOS CORPORATION; 11911 north creek parkway; bothell WA 98011 8809
• Manufacturer Contact: sandara bausback-aballo ; 300 conshohocken state rd,; 300 four falls corporate ctr.; west conshohocken, PA 19428-2998 ; 6103311537
• MDR Report Key: 9153115
• MDR Text Key: 166939413
• Report Number: 3001627457-2019-00029
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182324
• 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: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2019
• 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