MAUDE Adverse Event Report: EKOS CORP. EKOSONIC ENDOVASCULAR SYSTEM

Model Number 106 CM/30 CM

Device Problems Device Stops Intermittently (1599); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2015

Event Type  malfunction  

Event Description

Event desc: ekos catheter malfunctioned and removed from the pt.Reported to manager and the ekos representative.Device usage problem: device malfunction that is, the device did not do what it was supposed to do.Mfr's report: the customer reported that during use of the ekosonic system to treat a deep vein thrombosis, the control unit alarmed.Troubleshooting was unsuccessful and the procedure was completed using the ekosonic device as a standard infusion catheter.No pt injury was reported.

Manufacturer Narrative

Review of the log file from the control unit confirmed the device alarmed and turned off during use.However the cause of the alarm could not be determined from the log file.The returned ekosonic device was inspected and operated for four hours in a test fixture.The device operated normally with no recurrence of the reported alarm.The control unit was also returned and tested and no cause for the temperature alarm was found.Although the alarm during operation was confirmed, the returned device operated normally and the reported event could not be duplicated, nor could a cause be determined.

• Brand Name: EKOSONIC ENDOVASCULAR SYSTEM
• Manufacturer (Section D): EKOS CORP.; 11911 n creek parkway south; bothell WA 98011
• Manufacturer Contact: 11911 n creek parkway south; bothell, WA 98011 ; 4254153132
• MDR Report Key: 4973422
• MDR Text Key: 18208429
• Report Number: 3001627457-2015-00006
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081467
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/17/2015,06/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Model Number: 106 CM/30 CM
• Device Catalogue Number: 500-55130
• Device Lot Number: 140529025-004
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/29/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/01/2015
• Distributor Facility Aware Date: 06/17/2015
• Device Age: 12 MO
• Event Location: Hospital
• Date Manufacturer Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2014
• 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): Other
• Patient Age: 22 YR