MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY

Model Number	3256
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was canceled.The target lesion was located in the moderately calcified left anterior descending artery (lad).A rotapro console kit assy ul/ csa was selected for use.During platforming, the rpm is not stabilizing and is going faster and slower without any engagement.The procedure was aborted.No complications were reported.
Event or Problem Description
It was reported that the procedure was canceled.The target lesion was located in the moderately calcified left anterior descending artery (lad).A rotapro console kit assy ul/ csa was selected for use.During platforming, the rpm is not stabilizing and is going faster and slower without any engagement.The procedure was aborted.No complications were reported.It was further reported that the procedure was completed with another modality.
Event or Problem Description
It was reported that the procedure was canceled.The target lesion was located in the moderately calcified left anterior descending artery (lad).A rotapro console kit assy ul/ csa was selected for use.During platforming, the rpm is not stabilizing and is going faster and slower without any engagement.The procedure was aborted.No complications were reported.It was further reported that the procedure was completed with another modality.
Additional Manufacturer Narrative
H6: impact codes: corrected.Device evaluated by manufacturer: the device was returned for analysis.The console passed the final functional test without failing at any step, therefore the alleged malfunction cannot be confirmed.

• Brand Name: ROTAPRO
• 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.; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21233145
• Report Number: 2124215-2025-02393
• Device Sequence Number: 8630444
• Product Code: MCX
• UDI-Device Identifier: 08714729975076
• UDI-Public: 08714729975076
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P900056/S166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2025

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: Other
• Device Model Number: 3256
• Device Catalogue Number: 3256
• Device Lot Number: RP005741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2024
• Supplement Date Received by Manufacturer: 01/14/2025; 04/25/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 02/03/2025; 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2022
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown