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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 Failure to Prime (1492); Defective Component (2292); Noise, Audible (3273)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/02/2020
Event Type  malfunction  
Event Description
It was reported that the procedure was cancelled.An angiojet ultra system console and angiojet solent proxi catheter were selected for a thrombectomy procedure.However, the catheter did not prime.The procedure was cancelled.No patient complications were reported.
 
Event Description
It was reported that the procedure was cancelled.An angiojet ultra system console and angiojet solent proxi catheter were selected for a thrombectomy procedure.However, the catheter did not prime.The procedure was cancelled.No patient complications were reported.It was further reported that the drawer was making grinding noise when opened and closed.A problem on the roller pump was also suspected since waste tube needed to be manually held.
 
Manufacturer Narrative
Updated: b5 - describe event or problem and h6 - device code.
 
Manufacturer Narrative
Updated: b5 - describe event or problem and h6 - device code.Device evaluated by mfr.: the ultra console was received in good condition with no physical damages/defects observed.The ultra console was plugged in to wall outlet source and passed test steps.There was no error found on uic read out during the time of testing.The ultra system was loaded with set up catheter and run completed prime cycle without any problem therefore the priming issue was not confirmed.
 
Event Description
It was reported that the procedure was cancelled.An angiojet ultra system console and angiojet solent proxi catheter were selected for a thrombectomy procedure.However, the catheter did not prime.The procedure was cancelled.No patient complications were reported.It was further reported that the drawer was making grinding noise when opened and closed.A problem on the roller pump was also suspected since waste tube needed to be manually held.
 
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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 Key10697707
MDR Text Key211903440
Report Number2134265-2020-14337
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,Followup
Report Date 03/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2020
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 NumberU3853
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2021
Date Manufacturer Received03/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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