MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number 500-56150

Device Problems Fracture (1260); Device Handling Problem (3265)

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

Event Date 09/17/2017

Event Type  malfunction  

Manufacturer Narrative

The event log confirmed the reported all msd groups disabled alarm 36 minutes into the treatment.The investigation of the returned device on 26 september 2017 confirmed the msd shaft was fractured.The msd shaft was damaged with the rf common wire broken, which caused the msd failure.The optical microscopy evaluation noted a pinch mark on the msd shaft and damage 3cm from the end of the luer barb with exposing wires inside.It is likely that the complainant used a placement aid or tool during msd placement which contributed to the damage.Review of the device history record indicated that the device was manufactured according to specification and met all acceptance criteria prior to release.The instructions for use warn the user "do not deform or kink the msd during delivery into the iddc.If the msd is kinked at any time, do not attempt to use the msd, as kinking may lead to degraded performance or fracture during use." no serious injury was reported.The patient was reported as doing well.

Event Description

On 17 september 2017, it was reported that the device was placed successfully for a left leg arterial case with contralateral access but failed after 44 minutes with the alarm code - all msd groups disabled.All fluids were left running and the patient was reported as doing well.No further intervention was reported.The catheter was returned for evaluation.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Type of Device: CATHETER
• 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: rachael weir ; 11911 north creek parkway s; bothell, WA 98011-8809 ; 7325878533
• MDR Report Key: 6969780
• MDR Text Key: 90694912
• Report Number: 3001627457-2017-00029
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: 00858593006318
• 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,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2018
• Device Model Number: 500-56150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2016
• 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