MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT; CATHETER, CORONARY, ATHERECTOMY

Model Number	3240
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem 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.

• 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 Key: 10983895
• Report Number: 2134265-2020-17262
• Device Sequence Number: 19008468
• Product Code: MCX
• UDI-Device Identifier: 08714729353300
• UDI-Public: 08714729353300
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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 Number: 3240
• Device Catalogue Number: 3240
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 12/20/2020
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1