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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
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2021
Event Type  malfunction  
Event Description
It was reported that the procedure was cancelled.An angiojet ultra 5000a was selected for use in a thrombectomy procedure.Prior to procedure, an error prompted indicating a drawer malfunction.The console was turned off and back on and catheter was inserted multiple times but error still existed.The procedure was not completed due to this event.No patient complications were reported.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13015168
MDR Text Key282392363
Report Number2134265-2021-15867
Device Sequence Number1
Product Code MCX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 12/15/2021
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
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/29/2021
Initial Date FDA Received12/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient SexMale
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