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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
Medical Device Problem Code Output Problem (3005)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 04/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Date of event estimated as the first date of the aware month, as no event date was reported.
 
Event or Problem Description
Reportable based on additional information received on 06may2019.It was reported that unstable speed occurred.A rotablator rotational atherectomy system console kit was selected for use.It was observed that the rotation speed could not be controlled and was unstable.There were no patient complications reported.
 
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Brand Name
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT
Common Device Name
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8615614
Report Number2134265-2019-05321
Device Sequence Number14038226
Product Code MCX
UDI-Device Identifier08714729353300
UDI-Public08714729353300
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K121774
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/16/2019
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
Operator of Device Health Professional
Device Model Number3240
Device Catalogue Number3240
Device Lot NumberRC107437
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/24/2019
Initial Report FDA Received Date05/16/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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