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 Code	Ischemia Stroke (4418)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Hi-peitho clinical study.It was reported that ischemic cerebrovascular accident (cva) occurred, requiring intervention.On (b)(6) 2024, the subject underwent treatment with study device: ekosonic endovascular device, 106x12cm.Two ekos catheters were successfully placed, one in the right lower lobar artery and one in the left lower lobar artery.Therapy was initiated via the ekos device at a rate of 2mg/hr for a total dose of 7 mg across both the catheters on the same day.On (b)(6) 2024, the subject was diagnosed with ischemic cerebrovascular accident (cva).The event led to prolongation of hospitalization and intra-arterial therapy intervention.
Additional Manufacturer Narrative
A1: patient id: (b)(6).A2: patient age: 67 years old (at the time of enrollment).
Additional Manufacturer Narrative
A2: patient age: 67 years old (at the time of enrollment).
Event or Problem Description
It was reported that ischemic cerebrovascular accident (cva) occurred, requiring intervention.On (b)(6) 2024, the subject underwent treatment with study device: ekosonic endovascular device, 106x12cm.Two ekos catheters were successfully placed, one in the right lower lobar artery and one in the left lower lobar artery.Therapy was initiated via the ekos device at a rate of 2mg/hr for a total dose of 7 mg across both the catheters on the same day.On 17-dec-2024, the subject was diagnosed with ischemic cerebrovascular accident (cva).The event led to prolongation of hospitalization and intra-arterial therapy intervention.It was further reported that on (b)(6) 2024, the ekos catheters were successfully placed in the right femoral vein, right lower lobar artery and left lower lobar artery.In the context of the study, the patient received treatment with ekos and anticoagulation using heparin.On 17-dec-2024, the subject developed acute worsening of neurological function, for which cerebral computed tomography (ct) was performed.This showed a m1 clot in the left middle cerebral artery area.There were also signs of occlusion and clots in the left common carotid (lcc) and internal carotid artery (ica), for which stenting and thrombectomy were performed.The clot in m1 on the left was successfully removed.On 19-dec-2024, the subject was transferred from cardiology to neurology in connection with cva.A ct of the brain revealed no indications for intracranial bleeding, increase in demarcation of ischemia in the left hemisphere (middle flow area), with increased diffuse swelling and some mass effect on the left ventricles and known occlusion of the stent in the left cca, and no filling of the left ica.There was no basilar clot-clot, or new demonstrable occlusion in the right hemisphere and there was known extensive pulmonary embolisms, pleural fluid on the left was noted.Based on these findings, the reported event of ischemic cva with the onset of 17-dec-2024 based on the signs and symptoms.It was reported that it was a very complex case with a massive stroke and several thrombi, and the etiology was unknown.On 22-jan-2025, the subject was discharged to medical specialty rehabilitation on dalteparin.It was additionally reported that the cva was unrelated to the study devices and possibly related to the procedure and thrombolytic.

• 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): EKOS CORP INC; 11911 n. creek parkway s.; bothell WA 98011
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21126352
• Report Number: 2124215-2024-83114
• Device Sequence Number: 7464969
• Product Code: KRA
• UDI-Device Identifier: 00858593006134
• UDI-Public: 00858593006134
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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 Expiration Date: 06/29/2023
• Device Model Number: 6779-002
• Device Catalogue Number: 6779-002
• Device Lot Number: 0010876826
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/05/2025
• Date Device Manufactured: 07/29/2020
• 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: 2ND EKOS CATHETER; 2ND EKOS CATHETER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male