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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 3240
Device Problem Intermittent Loss of Power (4016)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/05/2021
Event Type  malfunction  
Event Description
It was reported that the procedure was cancelled.A rotablator rotational atherectomy system was selected for use.During the procedure, the console stalled.The procedure was not completed due to this event.There were no complications reported, and the patient was stable.
 
Event Description
It was reported that the procedure was cancelled.A rotablator rotational atherectomy system was selected for use.During the procedure, the console stalled.The procedure was not completed due to this event.There were no complications reported, and the patient was stable.It was further reported that the procedure was not completed due to a lack of console and the patient was not sedated when the issue occurred.
 
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Brand Name
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11197812
MDR Text Key227750130
Report Number2134265-2021-00416
Device Sequence Number1
Product Code MCX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/27/2021
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
Device Model Number3240
Device Catalogue Number3240
Device Lot NumberRC108730
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/06/2021
Initial Date FDA Received01/19/2021
Supplement Dates Manufacturer Received01/21/2021
Supplement Dates FDA Received01/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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