MAUDE Adverse Event Report: EKOS CORP. EKOSONIC ENDOVASCULAR SYSTEM; CATHETER, CONTINUOUS FLUSH

Model Number 135CM, 50CM

Device Problems Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2014

Event Type  malfunction  

Event Description

Two ekos devices were used sequentially in an attempt to place the devices over the aortic arch bifurcation: the 40 cm treatment zone drug infusion catheter was placed over the bifurcation and the ultrasound wire was then inserted into the drug infusion catheter.The ultrasound wire could not be fully inserted and was kinked.Both ultrasound wire and drug delivery catheter were removed.A 50 cm treatment zone drug infusion catheter was subsequently inserted, and the ultrasound wire was inserted into the drug infusion catheter.The physician indicated the ultrasound wire encountered strong resistance when trying to advance ver the bifurcation and broke.The physician was able to retrieve the fractured ultrasound wire by removing the drug infusion catheter.A standard infusion catheter was then used.F/u info indicated that there was no adverse effect to the patient as a result of the ekos device malfunction.

Manufacturer Narrative

The 40 cm (lot#-serial#: (b)(4)) and 50 cm (lot#-serial#: (b)(4)) devices were returned to ekos.Inspection of the 40 cm kit and 50 cm kit found pinch and kink marks on the working length consistent with difficulty in advancing the device.It was confirmed that the 50 cm ultrasound wire was fractured, with all components present on the returned fractured device.There was no other evidence of damage or abnormality.Review of the manufacturing records found no unusual processing procedures and the device passed all inspections.The condition of the devices was consistent with the reported event where the device was difficult to advance.The instructions for use caution the user not to continue using the device if it becomes kinked.F/u info indicated that there was no adverse effect to the patient as a result of the device malfunction.

• Brand Name: EKOSONIC ENDOVASCULAR SYSTEM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EKOS CORP.; 11911 n creek parkway south; bothell WA 98011
• Manufacturer Contact: 11911 n creek parkway south; bothell, WA 98011 ; 4254153114
• MDR Report Key: 3901859
• MDR Text Key: 4545513
• Report Number: 3001627457-2014-00009
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2016
• Device Model Number: 135CM, 50CM
• Device Catalogue Number: 500-56150
• Device Lot Number: 130611024-004
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/14/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/08/2014
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2014
• Date Manufacturer Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• 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