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

Model Number	6795-005
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device analysis: only the infusion catheter (ic) was returned for analysis.Visual inspection of the complaint device confirmed that there was a crack in the ic manifold luer which leaked liquid during the leak test.A leak through a crack in the manifold luer would have been a coolant leak, as the drug lumens are not connected to the central lumen.
Event or Problem Description
It was reported that the ekos device was leaking and required device exchange.An ekosonic endovascular device, 135x30cm was selected for use.At some point during the procedure or therapy, it was observed that the ekos device was leaking.It was not reported whether the leak was attributed to lytic or coolant.The ekos device was exchanged for a non-boston scientific infusion catheter.No further information was provided, despite request by boston scientific.
Event or Problem Description
It was reported that the ekos device was leaking and required device exchange.An ekosonic endovascular device, 135x30cm was selected for use.At some point during the procedure or therapy, it was observed that the ekos device was leaking.It was not reported whether the leak was attributed to lytic or coolant.The ekos device was exchanged for a non-boston scientific infusion catheter.No further information was provided, despite request by boston scientific.

• 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: 20880092
• Report Number: 2124215-2024-77048
• Device Sequence Number: 15404886
• Product Code: KRA
• UDI-Device Identifier: 00858593006295
• UDI-Public: 00858593006295
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6795-005
• Device Catalogue Number: 6795-005
• Device Lot Number: 8035223042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 12/14/2024
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown