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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Date 02/17/2024

Event Type  Injury  

Event Description

It was reported via attached literature article that a patient experienced a stroke within one year of receiving ekos therapy.For the study, the authors reviewed data from 56 patients treated for acute limb ischemia (ali) using ekos ultrasound-accelerated thrombolysis.All data was analyzed on each patient for one year following ekos intervention.Complications such as strokes, myocardial infarctions, and mortality were monitored for.From the data reviewed, no patients in the case series experienced myocardial infarction or death, and only one patient encountered a stroke within one year following ekos intervention.No further detail was provided regarding patient status for the patient who experienced the stroke.No other complications were revealed with a 100% success rate of procedures.

Manufacturer Narrative

A2 - age at time of event: the average patient age of all 56 patients was utilized.A3 - sex: as 75% of patients in the case series were male, male was selected as the patient sex.B3 - date of event: there was no event date provided in the literature article.As a result, the journal article publish date was utilized.Swarna, s., tran, v., pham, a., daley, s., ibrahim, a., jenkins, l., & ansari, m.M.(2024).300.16 utilization of ekos ultrasound-accelerated thrombolysis in the treatment of acute limb ischemia.Jacc: cardiovascular interventions, 17(4).Https://doi.Org/10.1016/j.Jcin.2024.01.296.

• Brand Name: EKOSONIC CATHETERS
• Type of Device: 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: 18969937
• MDR Text Key: 338503509
• Report Number: 2124215-2024-16665
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2024

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male