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

Model Number 500-55112

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

Patient Problems Bradycardia (1751); Cardiopulmonary Arrest (1765); Death (1802)

Event Date 05/04/2020

Event Type  Death  

Event Description

It was reported that a patient death occurred.An ekosonic catheter was selected for use during a bilateral pulmonary embolism procedure.Patient had history of uterine cancer and was admitted to the hospital on (b)(6) 2020 for cancer related symptoms.On (b)(6) 2020, patient sent for an eksonic procedure for pulmonary embolism (pe) treatment.During the procedure, patient was on bilevel positive airway pressure with oxygen saturations in the mid-80s.Patient was noted to be tachycardic, but stable.Placement of ekos catheter was successfully completed without incident and infusions started in the lab.Patient was sent to the intensive care unit and 5 minutes after arrival, patient went into cardiopulmonary arrest.At this time, chest compressions were performed with a cardiopulmonary assist machine for 20 minutes to stabilize the patient.Approximately 10 minutes later, patient became bradycardic and a second cardiopulmonary arrest occurred.Patient was then treated for the next 40 minutes before expiring.

• Brand Name: EKOSONIC KIT 106CM 12CM TZ
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BTG BOTHELL; bothell WA
• Manufacturer (Section G): BTG BOTHELL; bothell WA
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10095809
• MDR Text Key: 192384411
• Report Number: 2134265-2020-07077
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00858593006134
• UDI-Public: 00858593006134
• 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: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2022
• Device Model Number: 500-55112
• Device Catalogue Number: 500-55112
• Device Lot Number: 0190702070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 35 YR