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

Catalog Number 500-55150

Device Problems Fracture (1260); Device Inoperable (1663); Device Handling Problem (3265)

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

Event Date 06/26/2017

Event Type  malfunction  

Manufacturer Narrative

The catheter (sn: (b)(4)) was returned to ekos on 7/7/17 for evaluation.The catheter evaluation confirmed the ultrasound core was fractured and the fracture occurred at the shaft to treatment zone joint.Examination of the ultrasound core shows indications of a prior kink in the fracture region, and some bending on internal wires.During follow up, ekos qa was informed that the patient anatomy was not tortuous and free of any graft.A definitive root cause could not be identified.Ekosonic endovascular device instructions for use states: do not deform or kink the ultrasound core during delivery into the infusion catheter.If the ultrasound core is kinked at any time, do not attempt to use it, as kinking may lead to degraded performance or fracture during use.Review of the manufacturing records indicates that the product was manufactured according to specification following all applicable procedures and the finished device met all acceptance criteria prior to release.

Event Description

A 106cm/50cm ekosonic catheter (sn: (b)(4)) was used to treat a patient with peripheral arterial occlusion on (b)(6) 2017.After successfully placed infusion catheter (part of the ekosonic catheter) in the patient, the treating physician tried to place ultrasound core (the microsonic device) and the ultrasound core wire fractured inside the infusion catheter.The physician was able to retrieve ultrasound core by pulling out the infusion catheter and replacing with another ekos device.The procedure was completed and patient was doing well.

• 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: mei huang ; 11911 north creek parkway s; bothell, WA 98011-8809 ; 4254153180
• MDR Report Key: 6704798
• MDR Text Key: 79969555
• Report Number: 3001627457-2017-00017
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006189
• UDI-Public: 00858593006189
• 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: Other
• Type of Report: Initial
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/10/2019
• Device Catalogue Number: 500-55150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2017
• 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