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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EKOSONIC; CATHETER, CONTINUOUS FLUSH
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BOSTON SCIENTIFIC CORPORATION EKOSONIC; CATHETER, CONTINUOUS FLUSH Back to Search Results
Model Number 6779-002
Device Problem Output Problem (3005)
Patient Problems Pulmonary Embolism (1498); Chest Pain (1776); Dyspnea (1816)
Event Date 08/17/2021
Event Type  malfunction  
Event Description
Patient with history of constrictive pericarditis (cp?) presented to the emergency department with chest pain and shortness of breath.Patient found to have a saddle pulmonary embolism and emboli in bilateral main pulmonary arteries in each lobe.Patient needed a bilateral pulmonary arteriogram with catheter assisted thrombolysis and inferior vena cava filter placement.Both of the boston scientific (bs) ekosonic endovascular devices would not function when the medication was started.The physician attempted to maneuver catheter alongside the bs representative in the room.The physician and bs representative determined that the products were nonfunctioning and pulled them out and replace them with new ones.The replacements worked well.No known harm to patient.
 
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Brand Name
EKOSONIC
Type of Device
CATHETER, CONTINUOUS FLUSH
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key12376859
MDR Text Key268478515
Report Number12376859
Device Sequence Number1
Product Code KRA
UDI-Device Identifier00858593006134
UDI-Public(01)00858593006134(17)240315(10)8035013674
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number6779-002
Device Catalogue Number500-55112
Device Lot Number8035013674
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/19/2021
Event Location Other
Date Report to Manufacturer08/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age26280 DA
Patient Weight89
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