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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 45038
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2023
Event Type  malfunction  
Manufacturer Narrative
B1: event date --used the first date of the month of the aware date as no event date was provided.
 
Event Description
It was reported that the foot pedal failed to release.An angiojet ultra system console was selected for a thrombectomy procedure.However, after pushing the foot pedal, it did not return to the original position.There were no patient complications reported.
 
Manufacturer Narrative
B1: event date --used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr: the device was returned and analyzed.Inspection revealed that the foot switch was not functioning as intended.The pedal was repaired/replaced, and issue was resolved.Analysis confirmed the foot pedal issue reported from the field.
 
Event Description
It was reported that the foot pedal failed to release.An angiojet ultra system console was selected for a thrombectomy procedure.However, after pushing the foot pedal, it did not return to the original position.There were no patient complications reported.
 
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Brand Name
ANGIOJET ULTRA SYSTEM CONSOLE
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
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17798427
MDR Text Key324032859
Report Number2124215-2023-49378
Device Sequence Number1
Product Code MCX
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Remedial Action Notification
Type of Report Initial
Report Date 09/22/2023
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 NumberU9187
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/29/2023
Initial Date FDA Received09/22/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/06/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction Number92069759-FA
Patient Sequence Number1
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