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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 45037
Device Problems Suction Problem (2170); Defective Device (2588)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2020
Event Type  malfunction  
Event Description
It was reported that aspiration was lost.An angiojet ultra system console was used for thrombectomy procedure.During the procedure, the unit could not perform in power pulse mode.The unit also would not aspirate.The procedure was able to be completed with the same console without further incident or complication.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the ultra console was received in good condition with no physical damages/defects observed.The ultra console was plugged into the wall outlet source and failed 4.5 test steps.There was no uic display error during the time of testing, but the console drawer failed occlusion verification test during pressure test and because of this, there was no restriction on catheter tubing for aspiration because the roller pump remained open, roller pump pressure drops, no aspiration during power pulse.
 
Event Description
It was reported that aspiration was lost.An angiojet ultra system console was used for thrombectomy procedure.During the procedure, the unit could not perform in power pulse mode.The unit also would not aspirate.The procedure was able to be completed with the same console without further incident or complication.No patient complications were reported.
 
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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 Key11013714
MDR Text Key221760827
Report Number2134265-2020-17852
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,health
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 Number45037
Device Catalogue Number45037
Device Lot NumberU4355
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2021
Initial Date Manufacturer Received 12/08/2020
Initial Date FDA Received12/15/2020
Supplement Dates Manufacturer Received04/16/2021
Supplement Dates FDA Received05/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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