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

Model Number	3240
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the display on the device was not functioning a rotablator rotational atherectomy system console kit was selected for use.During preparation, it was noted that there was no rotations per minute (rpm) display on the console while the burr was rotating.The procedure was completed with another console.No complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The unit does not meet specifications for rotablator system functional test.When pressing the foot pedal to the console (with air valve open) and turning on the power in the console with the turbine pressure knob fully clockwise, no stall indicator appeared and causing consequently no rpm reading in the rotational speed rpm screen.The most probable root cause of the failure is a defective twa pcb board.No other product interaction with the device contributed to the reported failure.
Event or Problem Description
It was reported that the display on the device was not functioning a rotablator rotational atherectomy system console kit was selected for use.During preparation, it was noted that there was no rotations per minute (rpm) display on the console while the burr was rotating.The procedure was completed with another console.No complications reported.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8359097
• Report Number: 2134265-2019-01557
• Device Sequence Number: 19390415
• Product Code: MCX
• UDI-Device Identifier: 08714729719601
• UDI-Public: 08714729719601
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2019

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 Expiration Date: 12/31/1999
• Device Model Number: 3240
• Device Catalogue Number: 3240
• Device Lot Number: RC-2731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 67 YR