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

Catalog Number 500-56140

Device Problems Device Alarm System (1012); Material Fragmentation (1261)

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

Event Date 06/05/2016

Event Type  malfunction  

Manufacturer Narrative

Although the device broke externally in this case, there is potential harm, were the distal fractured fragment to remain in the patient.The complaint product and data event log were returned to ekos for evaluation.Review of the event log shows that three (3) types of alarms occurred between 13 to 17 hours in the therapy session for this patient.The total therapy time was 18 hours.Returned product was observed under microscope.This microscopic inspection reveals a reduced cross sectional area in the junction of the microsonic device (msd).This likely occurs due to kink during placement/advancement or non-compliant situation post-procedure.When ekos representative enquired, complainant could not confirm either of the aforementioned two scenarios.The kink most likely contributed to the alarms.Review of the manufacturing records indicate that the product was manufactured according to specifications and met all release criteria.Therefore, a definitive cause is not identifiable at this time.The product ifu contains a warning statement pertaining to kinking - " 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." ekos follow up indicates that the clinician had great end result.

Event Description

The report concerns a patient of unknown age and gender who underwent ekosonic for the treatment of a peripheral artery occlusion (le pao).No details of the patients medical history or concomitant medications were reported.The reporter contacted the helpline via text message due to a 'msd withdrawn' alarm being noted on the ekos control unit after eighteen (18) hours of therapy.The helpline contacted the reporting establishment and confirmed that the ultra sound core (usc) was hubbed and that the catheter had not been recently flushed at the time of the alarm.The reporter stated that during the removal procedure of the usc that it broke into two (2) pieces after being removed from the patient.The reporter was unable to confirm if any difficulty had been experienced during the placement of the device or whether the patient had remained compliant (laid still) during the duration fo the therapy.The reporter stated that the patient 'got a great ekos result and the usc wire did not harm the patient in any way' (verbatim).

• 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: benjamin hornsey ; 11911 north creek parkway s.; bothell, WA 98011-8809 ; 4254153143
• MDR Report Key: 5765863
• MDR Text Key: 48715303
• Report Number: 3001627457-2016-00018
• Device Sequence Number: 1
• Product Code: KRA
• 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: 06/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/15/2018
• Device Catalogue Number: 500-56140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2015
• 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