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 Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated as no event date was reported.
Event or Problem Description
It was reported that the device speed was unstable.A rotablator rotational atherectomy system console kit was selected for use.It was reported that rotational speed was not stable.There were no patient complications reported.
Additional Manufacturer Narrative
Date of event was approximated as no event date was reported.
Event or Problem Description
It was reported that the device speed was unstable.A rotablator rotational atherectomy system console kit was selected for use.It was reported that rotational speed was not stable.There were no patient complications reported.
Additional Manufacturer Narrative
Date of event was approximated as no event date was reported.Device evaluated by mfr: the console was received with a missing turbine pressure knob and the foot pedal is in good condition.The pressure gauge on the console would not read correctly the psi with air pressure activated.The pressure gauge for the test should be in the range of 85+/- 2psig, the actual reading instead was 81psig.The rpm display fails to show at 99000-101000 rpm.The rpm display is not off.The rpm diplay does not show 888,000 rpm.The most probable root cause of the failure is a defective turbine pressure control.
Event or Problem Description
It was reported that the device speed was unstable.A rotablator rotational atherectomy system console kit was selected for use.It was reported that rotational speed was not stable.There were no patient complications reported.

• 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: 8147218
• Report Number: 2134265-2018-63778
• Device Sequence Number: 1684047
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2019

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: RC108012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Initial Date Received by Manufacturer: 11/22/2018
• Supplement Date Received by Manufacturer: 01/28/2019; 03/05/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 02/11/2019; 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1