MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC; CATHETER, CONTINUOUS FLUSH

Model Number	6779-002
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	04/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the device was difficult to remove.This 106x12cm ekosonic catheter was selected for use during a bilateral pulmonary embolism thrombolysis procedure.After thrombolysis was complete, the ekos catheters were being removed, and the first catheter was removed without incident.The second catheter was very difficult to move and was noted to be stuck.The physician increased the pulling pressure slightly, but the patient began to complain of chest pain and a pulling feeling in the chest area.The ultrasound core wire was removed and the ekos infusion catheter was flushed before trying to pull and remove the catheter again.The physician increased the pulling force, the catheter was removed, and there were no physical defects observed with the catheter.The patient was noted to be doing fine and was later discharged from the hospital.

• Brand Name: EKOSONIC
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22018241
• Report Number: 2124215-2025-29508
• Device Sequence Number: 18306708
• Product Code: KRA
• UDI-Device Identifier: 00858593006134
• UDI-Public: (01)00858593006134
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K213422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6779-002
• Device Catalogue Number: 6779-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 05/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown