MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 135X50CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-56150
Medical Device Problem Codes	Break (1069); Electrical /Electronic Property Problem (1198); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device analysis: the ultrasonic core (usc) was observed to be broken at approximately 90cm from the luer barb, and the infusion catheter (ic) was kinked at approximately 78cm from the strain relief.Due to the damage to the usc, the device was unable to be tested functionally.The reported error message was unable to be confirmed; however, it was likely that the error messages were caused by the kinks in the device.
Event or Problem Description
Reportable based on device analysis completed on 17oct2023.An ekosonic endovascular device, 135x50cm was selected for use in a unilateral ekos procedure.After approximately 10 hours of ekos therapy, the control unit began displaying multiple error messages.Troubleshooting was unable to resolve the issue.It was not reported how the procedure was completed, but the patient status was reported as stable, but running a fever.However, device analysis revealed the ultrasonic core (usc) was fractured.

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 135X50CM
• 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: 18075048
• Report Number: 2124215-2023-62011
• Device Sequence Number: 15357421
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: 00858593006318
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 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: 11/25/2024
• Device Model Number: 500-56150
• Device Catalogue Number: 500-56150
• Device Lot Number: 8035070776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2023
• 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: 11/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown