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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 3240
Device Problem Device Remains Activated (1525)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/03/2020
Event Type  malfunction  
Event Description
It was reported that the rotation was unable to stop.A ce rotablator was selected for use.The foot pedal was damaged.Rotation would not stop for a while even if the foot was released from the foot pedal.No patient complications were reported.
 
Event Description
It was reported that the rotation was unable to stop.A ce rotablator was selected for use.The foot pedal was damaged.Rotation would not stop for a while even if the foot was released from the foot pedal.No patient complications were reported.It was further reported that the issue was noted during the procedure.The procedure was completed with the same device and the patient was good post procedure.
 
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Brand Name
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10983895
MDR Text Key220680769
Report Number2134265-2020-17262
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729353300
UDI-Public08714729353300
Combination Product (y/n)N
PMA/PMN Number
K121774
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 12/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3240
Device Catalogue Number3240
Was Device Available for Evaluation? No
Date Manufacturer Received12/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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