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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET ULTRA 5000A; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION ANGIOJET ULTRA 5000A; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 45038
Device Problems Display or Visual Feedback Problem (1184); Failure to Prime (1492)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/30/2019
Event Type  malfunction  
Event Description
It was reported that an error message was displayed.The patient presented with st-elevated myocardial infarction (stemi) and thrombus was located in right coronary artery (rca).A manual aspiration of the clot was done prior to using angiojet thrombectomy.An angiojet spiroflex catheter was inserted into an angiojet ultra 5000a console.However, an error message was shown during priming of the catheter and the device was having issues fully priming after several attempts were made.After reinserting the catheter, the device was able to prime.At this point, the catheter was inserted into the patient.While trying to utilize the thrombectomy in the rca, another error message appeared.During removal of the first catheter, a large amount of saline was pooling in the drawer of the console.Another spiroflex was opened.A similar experience occurred with the second catheter.The second catheter never entered the patient after similar error messages appeared.The procedure was successfully completed with a different device.No complications were reported.The patient was stable after the procedure and will be brought back for further percutaneous coronary intervention (pci) at a later date.
 
Manufacturer Narrative
Device evaluated by mfr.: the angiojet drawer assembly was received in san jose cis in good condition with no physical damages observed.Ultra system console and catheter were not returned for analysis.The drawer was installed into ultra system test fixtures and failed a test step.The user interface controller showed no error during the time of testing, but failed roller pump pressure spec value and because of this the catheter will leaks out fluid into the drawer and will not be able to prime.The unknown error probably due to the drawer failure but the leaks and priming difficulty issue was confirmed.
 
Event Description
It was reported that an error message was displayed.The patient presented with st-elevated myocardial infarction (stemi) and thrombus was located in right coronary artery (rca).A manual aspiration of the clot was done prior to using angiojet thrombectomy.An angiojet spiroflex catheter was inserted into an angiojet ultra 5000a console.However, an error message was shown during priming of the catheter and the device was having issues fully priming after several attempts were made.After reinserting the catheter, the device was able to prime.At this point, the catheter was inserted into the patient.While trying to utilize the thrombectomy in the rca, another error message appeared.During removal of the first catheter, a large amount of saline was pooling in the drawer of the console.Another spiroflex was opened.A similar experience occurred with the second catheter.The second catheter never entered the patient after similar error messages appeared.The procedure was successfully completed with a different device.No complications were reported.The patient was stable after the procedure and will be brought back for further percutaneous coronary intervention (pci) at a later date.
 
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Brand Name
ANGIOJET ULTRA 5000A
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9348276
MDR Text Key169267264
Report Number2134265-2019-14130
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729890584
UDI-Public08714729890584
Combination Product (y/n)N
PMA/PMN Number
P980037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/07/2020
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 NumberOEMTRACE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2020
Initial Date Manufacturer Received 10/30/2019
Initial Date FDA Received11/20/2019
Supplement Dates Manufacturer Received01/23/2020
Supplement Dates FDA Received02/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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