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

Model Number	6795-007
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ultrasonic core broke.A 135cm x 50cm ekosonic endovascular device was selected for use in a right lower extremity ultrasound-accelerated thrombolysis procedure for deep vein thrombosis (dvt).During the procedure inside the body, while attempting to remove and reposition the catheter into a better location, the ultrasonic core broke into two pieces.The procedure was completed using an alternate device.No patient complications were reported.
Event or Problem Description
It was reported that the ultrasonic core broke.A 135cm x 50cm ekosonic endovascular device was selected for use in a right lower extremity ultrasound-accelerated thrombolysis procedure for deep vein thrombosis (dvt).During the procedure inside the body, while attempting to remove and reposition the catheter into a better location, the ultrasonic core broke into two pieces.The procedure was completed using an alternate device.No patient complications were reported.

• 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: 21242097
• Report Number: 2124215-2025-03746
• Device Sequence Number: 3664046
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: 00858593006318
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 02/26/2025

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 Expiration Date: 07/31/2026
• Device Model Number: 6795-007
• Device Catalogue Number: 6795-007
• Device Lot Number: 8035744261
• 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: 01/02/2025
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 02/26/2025
• Date Device Manufactured: 08/01/2023
• 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