MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC; MECHANICAL THROMBOLYSIS CATHETER

Model Number	6779-002
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Detailed product information was not provided to bsc, and was unavailable per the customer.Although the device was returned to bsc, the device lot # was not visible on the returned components of the device.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.Device analysis: during visual inspection of the complaint device, it was found that there were cracks on the drug and coolant luers of the infusion catheter.It was also found that there was a kink in the ultrasonic core, approximately 7 cm from the luer barb.The drug and coolant luers did not leak during flushing, despite being cracked.However, it was observed that when the drug line was flushed, there was fluid leaking from under the infusion catheter strain relief.The strain relief was removed, and the infusion catheter tubing was observed to have a small hole in it which lined up with the ultrasonic core kink.
Event or Problem Description
It was reported that the ekos catheter was leaking at the device hub or manifold.An ekosonic device was selected for use to treat a bilateral pulmonary embolism.Two ekos devices were placed late in the evening.The following morning, staff observed that one of the ekos catheters was leaking.The leak was not reported as being clinically significant.The leak did not impact the administration of ultrasound or lytic, and thrombus resolution was achieved.There were no patient complications as a result of this event.However, device analysis revealed that there was a hole on a portion of the infusion catheter that would have entered the patient.

• Brand Name: EKOSONIC
• Common Device Name: MECHANICAL THROMBOLYSIS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; coyol ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22843838
• Report Number: 2124215-2025-57953
• Device Sequence Number: 9580900
• Product Code: QEY
• UDI-Device Identifier: 00858593006134
• UDI-Public: (01)00858593006134
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/19/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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