MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X30CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-55130
Medical Device Problem Codes	Device Alarm System (1012); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device analysis: the ultrasonic core (usc) was observed to be broken approximately 84cm from the luer barb, at the start of the treatment zone.Additionally, the treatment zone was severely kinked.Due to the damage to the usc, functional testing was unable to be performed.The reported error messages were unable to be confirmed; however, it was likely that the error messages were caused by the broken usc.
Event or Problem Description
Reportable based on device analysis completed on 17oct2023.An ekosonic endovascular device, 106x30cm was selected for use in a bilateral ekos procedure.After approximately 90 minutes of ekos therapy, there were multiple error messages observed on the control unit.Troubleshooting was unable to resolve the issue.The ekos device was ran as a standard infusion catheter without the use of ultrasound to complete the procedure.There were no reported patient complications.However, device analysis revealed the ultrasonic core (usc) was fractured.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 106X30CM
• 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: 18075173
• Report Number: 2124215-2023-62086
• Device Sequence Number: 7615707
• Product Code: KRA
• UDI-Device Identifier: 00858593006165
• UDI-Public: 00858593006165
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 11/06/2023

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: 05/12/2025
• Device Model Number: 500-55130
• Device Catalogue Number: 500-55130
• Device Lot Number: 8035099912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown