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

Model Number	3240
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Aware date used as event date, as no event date was reported.Device evaluated by mfr: the device was not returned, however was analyzed in the field.Field service records were reviewed which indicated that the device had an issue with the pressure regulator.The pressure regulator was replaced and the issue was resolved.
Event or Problem Description
It was reported that the rpm of the device was unstable.A rotablator rotational atherectomy system console kit was selected for use.During preparation, the rpm of the device did not increase more than 180,000 rpm.However, it suddenly increased up to 200,000 rpm inside the patient's body.

• 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: 8444098
• Report Number: 2134265-2019-02839
• Device Sequence Number: 14013755
• 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): 03/22/2019

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: RC107629
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1