MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number	500-55150
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of the returned device confirmed that the rf wires had shorted inside of the msd hub.A void was observed in the loctite connecting the strain relief to the white portion of the msd luer lock, which likely contributed to fluid ingress into the hub.It was reported that the msd was replaced, and no adverse patient outcome has been reported.The device short was not reported by the user.No definitive root cause could be identified.Review of the device history record confirmed that the product was manufactured per standard processes and met all acceptance criteria.There have been no other reported complaints from msds of the same lot.No patient harm was reported.
Event or Problem Description
It was reported that the microsonic device (msd) catheter would not run any longer than one minute during a dvt case.No fluid ingress or bent pins was found by the customer during troubleshooting.The control unit (cu) and connector interface cable (cic) was exchanged during troubleshooting, but the issue did not resolve.The msd was removed and replaced with a new one.No issues were encountered after exchanging the msd.The patient was reported to be doing fine.On 13 april 2020 a short was noted in the hub of the msd during investigation of the returned device.This was not reported by the customer.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Common Device Name: EKOSONIC ENDOVASCULAR CATHETER
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s; bothell, wa
• MDR Report Key: 9989392
• Report Number: 3001627457-2020-00012
• Device Sequence Number: 14412063
• Product Code: KRA
• UDI-Device Identifier: 00858593006189
• UDI-Public: 00858593006189
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/13/2020

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: 01/31/2021
• Device Model Number: 500-55150
• Device Catalogue Number: 500-55150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1