MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOS ENDOVASCULAR DEVICE; CATHETER, CONTINUOUS FLUSH

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

Patient Problems Cardiac Arrest (1762); Coma (2417); Obstruction/Occlusion (2422)

Event Date 02/01/2024

Event Type  Death  

Event Description

It was reported that the patient expired post ekos procedure.An ekos endovascular device was selected for use in the treatment of a saddle pulmonary embolism.Initial ekos therapy ran for 6 hours.When the catheter was pulled from the patient, the patient coded.50mg tpa was administered in an attempt to resolve it.The patient was transferred to another hospital.Pulmonary vessels were checked, and it was observed that the clot had resolved, but the patient was not responding neurologically.Ecmo was attempted, but the patient did not recover neurologically and then expired following a hospital stay of 5-6 days.

Manufacturer Narrative

B3: date of event: asked but unknown.Estimated using first day of aware month.

• Brand Name: EKOS ENDOVASCULAR DEVICE
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18848011
• MDR Text Key: 337024447
• Report Number: 2124215-2024-12687
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• 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
• Date Manufacturer Received: 02/10/2024
• 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): Hospitalization; Required Intervention; Death
• Patient Age: 45 YR
• Patient Sex: Female