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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 Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2023
Event Type  malfunction  
Event Description
It was reported that foot pedal stuck occurred.An angiojet console was used for a thrombectomy procedure.However, when the foot pedal is pressed, the device continues to pulsate fluid into the patient.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr: angiojet footswitch was received.A visual inspection was done on the footswitch, and it passed visual inspection.The received footswitch was installed onto the golden angiojet console.Then a functional test was performed.During the test, the console continued to pump even though there was no pressure applied to the footswitch.The complaint was confirmed.
 
Event Description
It was reported that foot pedal stuck occurred.An angiojet console was used for a thrombectomy procedure.However, when the foot pedal is pressed, the device continues to pulsate fluid into the patient.There were 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
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
150 baytech dr.
san jose CA 95134
Manufacturer Contact
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16644496
MDR Text Key312363427
Report Number2124215-2023-14123
Device Sequence Number1
Product Code MCX
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 Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/06/2023
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/08/2023
Initial Date FDA Received03/30/2023
Supplement Dates Manufacturer Received06/12/2023
Supplement Dates FDA Received07/06/2023
Was Device Evaluated by Manufacturer? Yes
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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