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

Model Number	6795-007
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by manufacturer: the device was returned for analysis.Microscopic visual inspection of the infusion catheter showed no abnormalities.The ultrasonic core, however, did show separation at 89.5cm from the strain relief.Functional testing could not be completed as a result.
Event or Problem Description
Reportable based on device analysis completed on 21apr2025.It was reported that error messages occurred.A 135x50cm ekosonic endovascular device was selected for use in the treatment of deep vein thrombosis.When in the interventional radiology (ir) suite, a device temperature too high error message occurred, so the pt3b console was swapped out for another one.The patient had just been transferred to the intensive care unit (icu) when it was observed that the pt3b was not running.When started, it took approximately five minutes for the same device temperature too high error message to occur again.Troubleshooting was unsuccessful.The device was powered down for five minutes, but upon turning back on and starting therapy, an all msd groups disabled error message appeared.Troubleshooting was again unsuccessful, so it was decided that the procedure would be completed without ultrasound using the catheter as a standard drip infusion catheter.There were no patient complications as a result of this event, and the patient was reported to be doing well.However, device analysis revealed that the ultrasonic core was separated.

• 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22038879
• Report Number: 2124215-2025-31823
• Device Sequence Number: 8509664
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: (01)00858593006318(17)280114(10)8035613562
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/16/2025

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: 6795-007
• Device Catalogue Number: 6795-007
• Device Lot Number: 8035613562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• 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