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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET ULTRA SYSTEM CONSOLE; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION ANGIOJET ULTRA SYSTEM CONSOLE; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 45038
Device Problems Display or Visual Feedback Problem (1184); Difficult to Open or Close (2921)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/11/2020
Event Type  malfunction  
Event Description
It was reported that the procedure was cancelled.An angiojet ultra system console was selected for a thrombectomy procedure.During preparation, the angiojet catheter was properly loaded on the console, but the drawer was blocked and could not be closed.A drawer error message displayed.As a result, the procedure was cancelled.No patient complications were reported.
 
Event Description
It was reported that the procedure was cancelled.An angiojet ultra system console was selected for a thrombectomy procedure.During preparation, the angiojet catheter was properly loaded on the console, but the drawer was blocked and could not be closed.A drawer error message displayed.As a result, the procedure was cancelled.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: angiojet drawer assembly received for analysis, however, the ultra system console and catheter were not returned for analysis.Visual examination of the device showed no physical damage.Functional analysis was done by completing the setup procedure.The drawer was installed into ultra system test fixtures and passed all test.The user interface controller showed no error during the time of testing.The unit was run on open/close drive for 100x with catheter load and the drawer always drive fully closed therefore the unit was blocked and not closed was not confirmed.Inspection of the remainder of the device, revealed no other damage or irregularities.
 
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Brand Name
ANGIOJET ULTRA SYSTEM CONSOLE
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11020650
MDR Text Key221803552
Report Number2134265-2020-17882
Device Sequence Number1
Product Code MCX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number45038
Device Catalogue Number45038
Device Lot NumberU8824
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2021
Initial Date Manufacturer Received 12/14/2020
Initial Date FDA Received12/16/2020
Supplement Dates Manufacturer Received04/16/2021
Supplement Dates FDA Received05/05/2021
Patient Sequence Number1
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