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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 Problems Defective Device (2588); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/22/2020
Event Type  malfunction  
Event Description
It was reported that the procedure was cancelled.A rotablator rotational atherectomy system was selected for use.Prior to the procedure, the rotablator equipment was not able to be connected to the gas supply.The procedure was cancelled.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.Prior to the procedure, the rotablator equipment was not able to be connected to the gas supply.The procedure was cancelled.There were no complications reported and the patient was stable.It was further reported that the size of the gas connector was not compatible with the machine joint.The patient was sedated when the issue occured and the proceudre was completed with another console.
 
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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 Key11127306
MDR Text Key225515023
Report Number2134265-2020-18607
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 01/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2021
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 NumberRC401716
Was Device Available for Evaluation? No
Date Manufacturer Received01/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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