MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO; catheter, coronary, atherectomy

Model Number	3256
Medical Device Problem Codes	Mechanics Altered (2984); Optical Problem (3001); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an erratic speed occurred.A rotapro console was selected for use.During the procedure, the speed was set to 180k rpm; however, the console displayed a speed of 230k rpm and could not be decreased.The device sounded like it was rotating faster than the set speed.Dynaglide mode was activated and the burr was removed.The procedure was completed with a cutting balloon.No complications were reported, and patient was stable post procedure.

• 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 ; +1(763)494-1632
• MDR Report Key: 24663630
• Report Number: 2124215-2026-15791
• Device Sequence Number: 9198406
• Product Code: MCX
• UDI-Device Identifier: 08714729975076
• UDI-Public: (01)08714729975076(11)210422(10)RP002932
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P900056/S166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2026

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: RP002932
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/10/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 07/27/2026
• Date Device Manufactured: 04/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown