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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 Problem Improper Flow or Infusion (2954)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/04/2020
Event Type  malfunction  
Event Description
It was reported that the procedure was cancelled.An angiojet ultra 5000a console was used for treatment.During use, it was noted that fluid was flowing back into the bag.The procedure was cancelled.No patient complications 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)
MINNETRONIX
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10066144
MDR Text Key191317367
Report Number2134265-2020-06609
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729890584
UDI-Public08714729890584
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P980037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/18/2020
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/04/2020
Initial Date FDA Received05/18/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/24/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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