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

Catalog Number 500-56112

Device Problems Occlusion Within Device (1423); Failure to Deliver (2338)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 04/19/2016

Event Type  malfunction  

Manufacturer Narrative

The therapy did not resolve the clot on the right side, therefore this is a reportable event.Having the clot remain, increases the risk of further pulmonary events in this patient.Two levels of investigation was performed - microscopic and functional.A microscopic review revealed the presence of blood in the drug lumen.The returned complaint sample appeared to have been aspirated with a syringe from all ports.Moderate difficulty was encountered while flushing from the drug port during the functional evaluation.The ifu directs users against blood draw procedures through the drug lumen.The root cause of this event therefore appears to be use/user related.

Event Description

Customer contacted the ekos helpline at the beginning of a bilateral pulmonary embolism (pe) case reporting an alarm on the right lung drug port pump.Hospital staff flushed the catheter using 4 x w/1cc syringe and the pump was restarted.After 10.5 hours the pump alarmed due to a downstream occlusion.Flushing was performed, with resistance noted.The pump pressure was increased to 'maximum' however the pump continued to alarm.The physician stopped the administration of the tissue plasminogen activator (tpa) to the right lung and continued the coolant through the catheter.Post cessation of the ekos therapy the physician attempted to extract the clot using penumbra, however no clot was aspirated.The physician deemed that the right lung clot was a 'chronic clot'(verbatim).The reporter stated that the patient 'did well' (verbatim) with therapy, with the left lung reported as 'mostly clear of clot'(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: 5671217
• MDR Text Key: 45700373
• Report Number: 3001627457-2016-00013
• 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: 04/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2018
• Device Catalogue Number: 500-56112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2016
• 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