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

Model Number	3240
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is an estimated date based off the aware date as the exact event date was not reported.(b)(6).
Event or Problem Description
It was reported that the speed was unstable.A rotablator rotational atherectomy system console was selected for use.During the procedure, the rotational speed was set at 180,000rpm; however, it was noted that the speed reached to 200,000rpm.Furthermore, the rotation speed was noted to be unstable.There were large difference between the rotational speed set outside the patient and the rotational speed at platform or at proximal of the lesion.The operator could not adjust the rotational speed as needed as the turbine pressure control knob is difficult and time log would occur in adjusting the rotation speed.No patient complications were reported and the patient's status post-procedure was good.

• 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: 8433394
• Report Number: 2134265-2019-02502
• Device Sequence Number: 1062976
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2019

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 Number: 3240
• Device Catalogue Number: 3240
• Device Lot Number: RC105800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1