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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 Problems Break (1069); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2024
Event Type  malfunction  
Event Description
It was reported that the catheter was fractured and detached.This 106x18cm ekosonic endovascular device was selected for use in a unilateral arterial leg procedure.During therapy, an e311 alarm was observed, which could not be resolved despite troubleshooting.The catheter was used as a standard infusion catheter without the use of ultrasound to complete the procedure.It was further reported that when the patient was brought to the catheterization laboratory and the ekosonic endovascular device was removed, the distal portion of the ultrasound wire was broken away from the wire.It was stable within the infusion catheter, and nothing was lost.There was no consequence to the patient; clot lysis had been achieved.The remaining clot was removed using angiojet, and the underlying lesions were treated with two percutaneous transluminal angioplasty balloons.
 
Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this ekosonic endovascular device was returned with the cables cut; therefore, functional testing was unable to be performed.Visual inspection of the device confirmed that the ultrasonic core (usc) was detached at approximately 95cm from the luer barb.The reported events were confirmed.
 
Event Description
It was reported that the catheter was fractured and detached.This 106x18cm ekosonic endovascular device was selected for use in a unilateral arterial leg procedure.During therapy, an e311 alarm was observed, which could not be resolved despite troubleshooting.The catheter was used as a standard infusion catheter without the use of ultrasound to complete the procedure.It was further reported that when the patient was brought to the catheterization laboratory and the ekosonic endovascular device was removed, the distal portion of the ultrasound wire was broken away from the wire.It was stable within the infusion catheter, and nothing was lost.There was no consequence to the patient; clot lysis had been achieved.The remaining clot was removed using angiojet, and the underlying lesions were treated with two percutaneous transluminal angioplasty balloons.
 
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Brand Name
EKOSONIC ENDOVASCULAR DEVICE, 106X18CM
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
2546 calle primera
alajuela
CS  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key19158859
MDR Text Key341007059
Report Number2124215-2024-24268
Device Sequence Number1
Product Code KRA
UDI-Device Identifier00858593006141
UDI-Public00858593006141
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K213422
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 04/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number500-55118
Device Catalogue Number500-55118
Device Lot Number8035078961
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/23/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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