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

Model Number	3256
Medical Device Problem Codes	Unstable (1667); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the rotation speed was not stable.A rotapro console was selected for use.During the procedure, burr is spinning at a higher speed than normal.There were no patient complications.
Additional Manufacturer Narrative
B3 - date of event: used the first day of the month of the bsc aware date as the event date was not provided.
Additional Manufacturer Narrative
B3 - date of event: used the first day of the month of the bsc aware date as the event date was not provided.
Event or Problem Description
It was reported that the rotation speed was not stable.A rotapro console was selected for use.During the procedure, burr is spinning at a higher speed than normal.There were no patient complications.It was further reported that actual speed observed was 135,000 rpm in dynaglide mode.The device sounded fast in dynaglide mode and was thought to be spinning faster than intended.
Additional Manufacturer Narrative
Corrected e3.Occupation and g2 report source.B3 - date of event: used the first day of the month of the bsc aware date as the event date was not provided.Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Risk review: a risk review was completed and confirmed that the event of system unexpected output - dynaglide mode (dynaglide mode rotation - speed unstable) was defined in the risk documentation.These event type have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, the investigation conclusion code for this complaint was considered cause traced to device design.
Event or Problem Description
It was reported that the rotation speed was not stable.A rotapro console was selected for use.During the procedure, burr is spinning at a higher speed than normal.There were no patient complications.It was further reported that actual speed observed was 135,000 rpm in dynaglide mode.The device sounded fast in dynaglide mode and was thought to be spinning faster than intended.

• 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): BOSTON SCIENTIFIC CORPORATION; 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: 23353901
• Report Number: 2124215-2025-73352
• Device Sequence Number: 13016465
• Product Code: MCX
• UDI-Device Identifier: 08714729975076
• UDI-Public: (01)08714729975076(11)230605(10)RP006733
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2026

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: 3256
• Device Catalogue Number: 3256
• Device Lot Number: RP006733
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 10/15/2025; 02/17/2026
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 11/14/2025; 03/13/2026
• Date Device Manufactured: 06/05/2023
• 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