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

Model Number	3240
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that display failure occurred.A rotablator console kit assy was selected for use.During the procedure, it was noted that the led display was blank and not working.The procedure was completed successfully.No patient complications were reported.
Additional Manufacturer Narrative
The device was not returned for analysis.Photos were provided by the site showing the back of the console as well as the display screen not functioning correctly in accordance with the reported events.Troubleshooting was performed by a service technician on site.The device was found contaminated and with blood stains on the pedal hose, pedal, console and pressure hose.The equipment was physically inspected, it has scratches on its casing and a knock on the acrylic of the console's internal pressure gauge, as well as on the acrylic that covers the rpm display.The pedal has scratches and stains, the double pressure gauge is in good physical condition.During functionality tests, the equipment completed its initial self-test, the event and procedure time displays lit up, the green power led lit up, the fiber port led lit up correctly.The equipment did not present leaks in the circuit.The equipment marked the revolutions per minute each time the pedal was pressed.The dygnalide function and stall alarm activated.According to the functionality test, it was not possible to replicate the error, the equipment was started several times and rotation tests of the demo were carried out 2-5-10-15 seconds, in all the tests the display showed the speed of the rotalink.To try to replicate the error, the demo's fiber optic cables were disconnected.When trying to activate it, the error appeared along with the activation of the stall alarm.Electrical safety test was carried out, and values were within range.No other issues were identified during the troubleshooting.The equipment passed the functionality tests and it was not possible to replicate the error having a functional rotalink demo, when the fiber optic cables were disconnected, the equipment tried to activate, however, the display did not show anything and the stall alarm was automatically activated, according to this last test, it can be deduced that the cause of the error was the device they were using in the procedure, which presented damage to the fiber optic connection.The equipment was determined to be functional and available for use.
Event or Problem Description
It was reported that display failure occurred.A rotablator console kit assy was selected for use.During the procedure, it was noted that the led display was blank and not working.The procedure was completed successfully.No patient complications were reported.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CONSOLE KIT
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): EP TECHNOLOGIES, INC.; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16534911
• Report Number: 2124215-2023-11790
• Device Sequence Number: 6389267
• Product Code: MCX
• UDI-Device Identifier: 08714729353300
• UDI-Public: 08714729353300
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 05/26/2023

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: RC108767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2013
• 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: Unknown