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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X18CM; CATHETER, CONTINUOUS FLUSH
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BOSTON SCIENTIFIC CORPORATION EKOSONIC ENDOVASCULAR DEVICE, 106X18CM; CATHETER, CONTINUOUS FLUSH Back to Search Results
Model Number 500-55118
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intracranial Hemorrhage (1891); Loss of Vision (2139)
Event Date 01/09/2023
Event Type  Death  
Event Description
It was reported that the patient experienced an intracerebral brain hemorrhage (ich) and was transferred to another facility for a higher level of care.On (b)(6) 2023, the patient was treated with two ekos devices.An ekosonic endovascular device, 135x12cm and an ekosonic endovascular device, 106x18cm were selected for use.Treatment was completed with no device issues reported.The ekos devices were discarded following treatment.On (b)(6) 2023, the patient experienced an ich and was transferred to another facility for a higher level of care.It was unknown whether the devices or procedure contributed to the ich.There were no further reported patient complications.
 
Manufacturer Narrative
Premarket 510(k) # k183361; k182324.
 
Manufacturer Narrative
G4: premarket 510(k) # k183361; k182324.
 
Event Description
It was reported that the patient experienced an intracerebral brain hemorrhage (ich) and was transferred to another facility for a higher level of care.On (b)(6) 2023, the patient was treated with two ekos devices.An ekosonic endovascular device, 135x12cm (16103547) and an ekosonic endovascular device, 106x18cm (16108301) were selected for use.Treatment was completed with no device issues reported.The ekos devices were discarded following treatment.On (b)(6) 2023, the patient experienced an ich and was transferred to another facility for a higher level of care.It was unknown whether the devices or procedure contributed to the ich.There were no further reported patient complications.It was further reported that prior to the index procedure on (b)(6) 2023, the patient was admitted for shortness of breath.A ct scan was performed to search for pulmonary embolism, and echocardiography confirmed a dilated right ventricle.Ekos treatment was performed for 6 hours.Following completion of the ekos treatment, upon device removal, the patient complained of right peripheral vision loss.Following the transfer to another facility, the patient was treated with a nicardipine drip and 1g of tranexamic acid.A ct scan was repeated on arrival and the bleed appeared to remain stable at the time.An ivc filter was placed to treat the patient's deep vein thrombosis.The patient ultimately expired on (b)(6) 2023.
 
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Brand Name
EKOSONIC ENDOVASCULAR DEVICE, 106X18CM
Type of Device
CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
marlborough MA 01752
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key16294398
MDR Text Key308754541
Report Number2124215-2023-03671
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/09/2023
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
Device Model Number500-55118
Device Catalogue Number500-55118
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/10/2023
Initial Date FDA Received02/03/2023
Supplement Dates Manufacturer Received02/10/2023
Supplement Dates FDA Received03/09/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
EKOSONIC ENDOVASCULAR DEVICE, 135X12CM; EKOSONIC ENDOVASCULAR DEVICE, 135X12CM
Patient Outcome(s) Hospitalization; Death; Life Threatening;
Patient SexMale
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