MAUDE Adverse Event Report: EKOSONIC ENDOVASCULAR CATHETER EKOSONIC ENDOVASCULAR CATHETER

Catalog Number	500-55150
Medical Device Problem Code	Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ekosonic kit was returned with an intact msd and iddc with the cable and the drug and coolant ports cut off; none of the cut off pieces of the iddc were returned.Investigation of the msd found the frequency on group 1 was programmed with a frequency outside of the specified limits which caused the alarm and the ekosonic control unit (cu) not being able to run and provide ultrasound.This ultimately led to the account not using ultrasound during treatment.Patient was reported to have residual thrombus after treatment and underwent an additional procedure with angiojet for further thrombus clearance.Patients having residual thrombus is a recurrent risk with dvt.Cdt is an acceptable treatment for thrombus management.In this case, intervention was required for dvt management.Patient was reported to be in good condition.The treating physician did not feel like ekos contributed to the hematoma.
Event or Problem Description
On (b)(6) 2019, a helpline call reported a "msd not functional" alarm after a unilateral dvt procedure.The msd had gone in smoothly.The alarm was not resolved.Treatment proceeded with using the ekos catheter as a catheter-directed thrombolysis/with lytic only (cdt).The icu nurse reported that a stat-lock type of device was used to hold catheter in place.When fluids were hooked up, the system sounded a downstream occlusion alarm on the iv pump.The nurse had to remove the "stat-lock" to get fluids to run.The patient was reportedly fine and stable.On (b)(6), the territory manager reported that, during follow-up, a venogram showed that there was still thrombus in the common femoral down to the popliteal.The physician used angiojet which cleared the rest of the thrombus.The patient was taken back to icu in good condition.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Common Device Name: EKOSONIC ENDOVASCULAR CATHETER
• Manufacturer (Section D): EKOSONIC ENDOVASCULAR CATHETER; 11911 north creek parkway s; bothell WA 98011 8809
• MDR Report Key: 8560727
• Report Number: 3001627457-2019-00016
• Device Sequence Number: 1666459
• Product Code: KRA
• UDI-Device Identifier: 00858593006189
• UDI-Public: 00858593006189
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/12/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 500-55150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other