MAUDE Adverse Event Report: EKOS CORPORATION EKOSONIC KIT 106CM 12CM TZ; CATHETER, CONTINUOUS FLUSH

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

Patient Problems Cardiac Arrest (1762); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914)

Event Date 06/25/2017

Event Type  Injury  

Event Description

It was reported that cardiac arrest occurred.On (b)(6) 2017, the subject was enrolled in the retrospective cohort of the knockout pe trial and index procedure was initiated on the same day.The lesion was identified in right lower lobar artery and the catheter was placed in the right jugular vein.Tissue plasminogen activator (tpa) was infused at a rate of 2 mg/hr for a total dose of 12mg.During the procedure, patient sustained a cardiac arrest with associated hypotension, dyspnea and altered mental status.At this time, patient was intubated and underwent cardiopulmonary resuscitation (cpr) procedure.The event was considered resolved that day.On (b)(6) 2017, patient was discharged home.No further information is known at this time.This report will be updated should additional information become available.

• Brand Name: EKOSONIC KIT 106CM 12CM TZ
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): EKOS CORPORATION; 11911 north creek parkway s.; bothell WA 98011
• Manufacturer (Section G): EKOS CORPORATION INC.; 11911 n. creek parkway s.; bothell WA 98011
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11612689
• MDR Text Key: 243721982
• Report Number: 2134265-2021-04202
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2021
• Initial Date FDA Received: 04/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR