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

Model Number	3240
Medical Device Problem Codes	Unstable (1667); Output Problem (3005)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.A rotablator rotational atherectomy system console kit was selected for use in a rotational atherectomy procedure.During the procedure, the rotalink plus was connected and the rotation speed was adjusted.However, there was no response from the equipment to the speed adjustment of the control knob leading to high revolutions without control.The procedure was unsuccessful and was cancelled.No patient complications complications were reported.
Event or Problem Description
It was reported that the procedure was cancelled.A rotablator rotational atherectomy system console kit was selected for use in a rotational atherectomy procedure.During the procedure, the rotalink plus was connected and the rotation speed was adjusted.However, there was no response from the equipment to the speed adjustment of the control knob leading to high revolutions without control.The procedure was unsuccessful and was cancelled.No patient complications were reported.It was further reported that the operating speed is set according to the size of the burr; a set speed does not come by default.The maximum speed reached is 260 rate per minute (rpm).The operating speed could not be established as the equipment did not respond to the rpm setting.To complete the procedure, high pressure balloons were used to modify the plate and implant the stent.The patient is stable and on medical discharge.

• 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: 10489280
• Report Number: 2134265-2020-12234
• Device Sequence Number: 2553208
• Product Code: MCX
• UDI-Device Identifier: 08714729353300
• UDI-Public: 08714729353300
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2020

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
• Device Lot Number: RC109006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 78