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	09/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that console had erratic speed.A rotablator rotational atherectomy system console kit was selected for use.During the procedure, it was noted that the rpm numbers were fluctuating without the dial being touched at all.The numbers will go from 120rpm to 220rpm to 150rpm to 120rpm.The procedure was being aborted and not resolved.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The console and the foot pedal were tested using a functional generator with frequencies and the reading were operational speeds within specification.The foot pedal functioned properly, readily activating/deactivating the rotation and switching the console between turbine and dynaglide modes.No other issues were reported.
Event or Problem Description
It was reported that console had erratic speed.A rotablator rotational atherectomy system console kit was selected for use.During the procedure, it was noted that the rpm numbers were fluctuating without the dial being touched at all.The numbers will go from 120rpm to 220rpm to 150rpm to 120rpm.The procedure was being aborted and not resolved.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: 7943475
• Report Number: 2134265-2018-61660
• Device Sequence Number: 13792007
• Product Code: MCX
• UDI-Device Identifier: 08714729353300
• UDI-Public: 08714729353300
• Combination Product (Y/N): N
• 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): 01/08/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 01/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR