MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER; CATHETER, CONTINUOUS FLUSH

Catalog Number 500-55112

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

The event log from the control unit (pt3b-6041) was downloaded on 12/09/2016.The event log data confirmed that the worn out catheter (sn: (b)(4)) contributed to the alert notifications reported by the customer, and also confirmed the ultrasound assisted therapy performed for about 18 hours without any issues before the alert notification.The event log data documents that the control unit operated as designed and ended the ultrasound when the error condition was detected.The condition all msd groups disabled is used to notify users when the ultrasound transducers no longer produce ultrasound.The catheter (sn: (b)(4)) was returned to ekos for evaluation on 01/16/2017.The catheter evaluation revealed the evidence of ultrasound core wear and tear.The manufacturing records were reviewed and the catheter was manufactured according to manufacturing specifications and released after meeting all acceptance criteria.

Event Description

On (b)(6) 2016, the customer called ekos helpline and reported an all msd group disabled alert notification after 18.5 hours of treatment in a deep vein thrombosis case.An ultrasound assisted therapy was started with an ekosonic mach4 106cm/12cm catheter (sn: (b)(4)) and ekosonic control unit (sn: (b)(4)) on (b)(6) 2016.Prior to the helpline call, the nurse attempted to troubleshoot by securing connections and rebooting the control unit, but it did not resolve the issue.Ekos helpline representative, after following troubleshooting steps, found that the catheter's ultrasound core was likely worn out which contributed to the alert notification.The customer was instructed to turn the control unit (ultrasound) off and continue the therapy with the ekosonic catheter as standard infusion catheter.Follow up from local ekos representative indicated that the control unit was off and the patient was doing well.There were no interruptions of infusions.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: mani shanmugham ; 11911 north creek parkway s; bothell, WA 98011-8809 ; 4254891279
• MDR Report Key: 6350012
• MDR Text Key: 68116328
• Report Number: 3001627457-2017-00009
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006134
• UDI-Public: 00858593006134
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/10/2019
• Device Catalogue Number: 500-55112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2016
• 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 Age: 43 YR