MAUDE Adverse Event Report: EKOSONIC ENDOVASCULAR CATHETER EKOSONIC ENDOVASCULAR CATHETER

Catalog Number	500-56130
Medical Device Problem Code	Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device and event log were returned.The event log from the case confirmed the reported "all msd disabled" alarm at 10.9 hours into therapy due to the phase angle for the ultrasound groups going outside of the operational threshold.The event log shows the cu functioned as expected.Investigation of the returned device revealed heat coming from the black msd hub after five minutes of run time on an in-house cu.Then, the cu alarmed with "all msd disabled" and the msd would no longer run.Investigation into the msd hub revealed all wires were shorted, potentially caused by fluid ingress into the hub.The route of fluid ingress into the hub is undetermined.During manufacturing, msd are 100% tested and a short would be detected during the final impedance test.Therefore, it is likely that fluid ingress occurred during use.Review of the manufacturing records confirmed the catheter was manufactured according to existing specifications; therefore, the damage observed on the received device is likely the result of use/handling that occurred outside of ekos.
Event or Problem Description
On (b)(6) 2019, a helpline call reported the cu alarming with code "all msd disabled" after10 hours and 50 minutes of therapy.The alarm could not be resolved over the phone with the ekos representative.The caller was instructed to alert the physician that catheter would have to be used as a standard infusion catheter.Final patient outcome was reported as great.There was complete clot clearance and the physician was very happy with the results.

• 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: 8560724
• Report Number: 3001627457-2019-00015
• Device Sequence Number: 1836260
• Product Code: KRA
• UDI-Device Identifier: 00858593006295
• UDI-Public: 00858593006295
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 500-56130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2019
• 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