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

Model Number	3259
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
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, rotapro will not hold a steady rpm.The rotations per minute are bouncing from 4k to 100k and all over the place.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer.The complaint device was received for product analysis.Console is running firmware version v05.18.00.Console passed the final functional test without failing at any step.Console failed the visual inspection because there are visible marks on the front panel, as well as visible marks and scratches on the rear housing.Due to the fact that the console was manufactured in (b)(6), it will have to be scrapped.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the rotation speed was not stable.A rotapro console was selected for use.During the procedure, rotapro will not hold a steady rpm.The rotations per minute are bouncing from 4k to 100k and all over the place.No patient complications were reported.

• 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; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22772989
• Report Number: 2124215-2025-54782
• Device Sequence Number: 9341727
• Product Code: MCX
• UDI-Device Identifier: 08714729975106
• UDI-Public: (01)08714729975106(11)190405(10)RP000460
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

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: 3259
• Device Catalogue Number: 3259
• Device Lot Number: RP000460
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2019
• 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