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

Model Number	3240
Medical Device Problem Codes	Unstable (1667); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the speed was exceeded the set rotational speed.The 85% stenosed target lesion was located in the left anterior descending artery.A ce rotablator was selected for use.During the procedure, the rotation speed could not be adjusted precisely by turbine pressure control knob.It seems that the knob was loose.Consequently, it was noted that the observed maximum speed was 200,000rpm vs set rotational speed of 160,000rpm.The procedure was completed with this device.No complications were reported and patient was stable post procedure.

• 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
• Manufacturer (Section G): EP TECHNOLOGIES, INC.; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16455815
• Report Number: 2124215-2023-08718
• Device Sequence Number: 6382401
• Product Code: MCX
• UDI-Device Identifier: 08714729353300
• UDI-Public: 08714729353300
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2023

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: RC107867
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2023
• Initial Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female