MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 135X12CM; CATHETER, CONTINUOUS FLUSH

Model Number	500-56112
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Peerless study.It was reported that the ekos device was leaking from both the drug and coolant lines, and the patient was returned to the catheterization lab for device exchange.An ekosonic endovascular device, 135x12cm was selected for use in the right pulmonary artery.Upon transfer to the critical care unit (ccu), it was observed that the infusion catheter in the right pulmonary artery was leaking from both the drug and coolant lines.The subject was returned to the catheterization lab and the ekos device was exchanged to resolve the issue.There were no further patient or procedure details available.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).

• Brand Name: EKOSONIC ENDOVASCULAR DEVICE, 135X12CM
• 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
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18763723
• Report Number: 2124215-2024-09180
• Device Sequence Number: 19930241
• Product Code: KRA
• UDI-Device Identifier: 00858593006264
• UDI-Public: 00858593006264
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Study,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2024

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: 500-56112
• Device Catalogue Number: 500-56112
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2024
• Initial Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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