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

Model Number	500-56150
Medical Device Problem Codes	Leak/Splash (1354); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ekos therapy was discontinued as a result of a leak, and the patient did not receive an adequate amount of lytic.An ekosonic endovascular device, 135x50cm was selected for use.During ekos therapy, an overheating alarm sounded, and upon moving the patient, it was noted that the hub of the ekos device was leaking.It was unconfirmed whether the leak was attributed to coolant or lytic, but the physician believed the leak to be lytic.Ultrasound therapy was discontinued, and the ekos device was continued to be used as a standard infusion catheter, despite the leak.Thrombus resolution was not achieved, and the physician reported that the patient did not receive an adequate amount of lytic.There were no reported patient complications.
Event or Problem Description
It was reported that ekos therapy was discontinued as a result of a leak, and the patient did not receive an adequate amount of lytic.An ekosonic endovascular device, 135x50cm was selected for use.During ekos therapy, an overheating alarm sounded, and upon moving the patient, it was noted that the hub of the ekos device was leaking.It was unconfirmed whether the leak was attributed to coolant or lytic, but the physician believed the leak to be lytic.Ultrasound therapy was discontinued, and the ekos device was continued to be used as a standard infusion catheter, despite the leak.Thrombus resolution was not achieved, and the physician reported that the patient did not receive an adequate amount of lytic.There were no reported patient complications.
Additional Manufacturer Narrative
Device analysis: visual inspection of the complaint device confirmed that there was a crack in the manifold luer.Functional testing confirmed that liquid was leaking from the crack.The reported event of leaking was confirmed.Additionally, it was found that the manifold luer was cracked.The reported event of an overheating alarm was not confirmed, but it was likely that leaking coolant from the manifold led to insufficient coolant irrigation, and a temperature alarm.

• 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: 18789780
• Report Number: 2124215-2024-11370
• Device Sequence Number: 15537030
• Product Code: KRA
• UDI-Device Identifier: 00858593006318
• UDI-Public: 00858593006318
• 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): 03/22/2024

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: 500-56150
• Device Catalogue Number: 500-56150
• Device Lot Number: 8035889541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown