MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC ENDOVASCULAR CATHETER

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Atrial Fibrillation (1729)

Event Date 12/03/2018

Event Type  Injury  

Manufacturer Narrative

The patient experienced atrial fibrillation following the removal of the ekos catheters following an 8 hour treatment for a bilateral pe.The treatment stopped on (b)(6) 2018 at 01:29 and the patient experienced a-fib at 05:30.The time the catheters were removed from the patient was not reported.Cardiac arrhythmias are a potential complication listed in the ifu most frequently occurring during placement, removal or following displacement into the right ventricle.This clinical study sae is considered to be procedure-related and not related to the ekos device.No additional information will be available.

Event Description

Subject (b)(6) is a retrospective patient enrolled in the (b)(6) study - (b)(6).This patient is a (b)(6) female.Clinical history and risk factors were reported (b)(6) with a 31.7 bmi; baseline 12 lead ecg was completed with abnormal results: "a-fib incomplete right bbb nonspecific st and t was abnormalities".This patient has a history of high cholesterol, hypertension, bmi>30.0.This patient was treated for a bilateral pe on (b)(6) 2018 for approximately 8 hours.12 mg of tpa were administered through each device (left pulmonary and right pulmonary arteries).The planned therapy was completed at 01:29 on (b)(6) 2018.The sae (new onset of moderate atrial fibrillation) started at 05:30 on (b)(6) 2018 and resolved on 15:15 (b)(6) 2018 and resulted in the need for non-surgical drug treatment, cardioversion and prolongation of hospitalization.The principle investigator classified the relationship of the new onset of atrial fibrillation as not related to the ekos device, thrombolytic drug and anticoagulant drug, but reported the relationship between the event and the interventional procedure as unknown.

Manufacturer Narrative

This is a follow up #1 to update the principle investigator's assessment of relatedness to the interventional procedure and to update the conclusion code accordingly.On 11 feb 2019, the principle investigator updated the relationship between the event and the interventional procedure from unknown to not related.This event (atrial fibrillation) is not related to the interventional procedure or the ekos device.The cause of the atrial fibrillation is unknown.

Event Description

This is a follow up #1 to update the principle investigator's assessment of relatedness to the interventional procedure and to update the conclusion code accordingly.On 11 feb 2019, the principle investigator updated the relationship between the event and the interventional procedure from unknown to not related.

• Brand Name: EKOSONIC ENDOVASCULAR CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s; bothell WA 98011 8809
• MDR Report Key: 8370744
• MDR Text Key: 137167961
• Report Number: 3001627457-2019-00007
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• PMA/PMN Number: K182324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 57 YR