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

Model Number	6779-002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extravasation (1842); Hematoma (1884); Swelling/ Edema (4577)
Date of Event	02/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the subject experienced right sided inguinal hematoma with scrotal involvement requiring prolonged hospitalization and medication.On (b)(6) 2025, subject was randomized to the study.Anticoagulation and ekos index procedure were performed on the same day.Two ekos devices were successfully placed in the right pulmonary artery and left pulmonary artery.Therapy was initiated via the ekos devices at a rate of 2mg/hr for a total dose of 7 mg across both catheters on same day.On (b)(6) 2025, the subject was noted to have increasing tenderness and hard swelling around right groin region where the venous catheter site was accessed.Subject was also noted to have increased swelling and purple discoloration that worsened over a day.A ct of abdominal and pelvis was performed which revealed, small foci of active bleeding in the subcutaneous tissues of the right groin, adjacent right inguinal hematoma extends into the right scrotum and towards the right flank.Bilateral central and segmental pulmonary emboli with overall decreased clot burden when compared to (b)(6) 2025.The bleed was determined to be venous in origin and should respond to pressure.Apixaban was started.The severity of the event was noted to be mild, and the event led to prolongation of hospitalization.On (b)(6) 2025, subject had significant improvement in tenderness and swelling began to improve.Anticoagulation was restarted and subject was hemodynamically stable before discharge.On (b)(6) 2025 the subject was discharged.
Additional Manufacturer Narrative
A2 - age at time of event: the subject was 73 years old at the time of study enrollment.D4 - lot number: there were two potential lot numbers for the device; 8035188332 or 8035347912.

• 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: 21638098
• Report Number: 2124215-2025-16847
• Device Sequence Number: 15587511
• Product Code: KRA
• UDI-Device Identifier: 00858593006134
• UDI-Public: 00858593006134
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 6779-002
• Device Catalogue Number: 6779-002
• Device Lot Number: 8035188332
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 03/18/2025
• Date Device Manufactured: 03/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EKOSONIC ENDOVASCULAR DEVICE, 106X12CM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White