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	11/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device analysis: visual inspection revealed that the usc had a break at 90cm from the strain relief, and 50cm of the usc was stuck inside the infusion catheter (ic).Microscopic inspection revealed that the usc appeared to have been broke at the beginning of the treatment area on the catheter.The usc was unable to be tested for the reported complaint due to the break in the catheter.
Event or Problem Description
It was reported that there was an e311 error during the initial procedure.An ekosonic endovascular device, 135x50cm was selected for use in a unilateral thrombectomy procedure.The ekos device was prepped and deployed in the usual fashion without difficulty.The catheter was placed and hooked up to all infusing fluids.Upon connection of the ekos device to the ekos cu 4.0 console, there was an e311 error on the console.Multiple troubleshooting attempts were made, but the error persisted.The ekos device was plugged into a pt3b, which experienced an error as well.The ekos device was exchanged, and the issue was resolved.There were no reported patient complications.However, device analysis revealed that the ultrasonic core (usc) was fractured.

• 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: 21150041
• Report Number: 2124215-2024-83949
• Device Sequence Number: 15864439
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: 00858593006318
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 01/14/2025

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: 6795-007
• Device Catalogue Number: 6795-007
• Device Lot Number: 8035454092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2024
• 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