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	02/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.A rotapro console were selected for use.During preparation, it was noted that the speed remained at 140k when the dynaglide mode was on.The procedure was not completed due to this event.The patient was stable after the procedure.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).Device evaluated by manufacturer: the complaint device was received for product analysis.The rotapro console failed the cis rotapro manual test due to an air leak from the pneumatic kit.The failure was detected at the portion of testing for the advancer dyna mode button functionality test.The detected flowrate was out of the specified range.Product analysis confirmed the reported events, as the speed during dynaglide mode is not functioning properly during the cis functional test.The cause was traced to a faulty pneumatic kit.
Event or Problem Description
It was reported that the procedure was cancelled.A rotapro console were selected for use.During preparation, it was noted that the speed remained at 140k when the dynaglide mode was on.The procedure was not completed due to this event.The patient was stable after the 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; 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: 21508044
• Report Number: 2124215-2025-11561
• Device Sequence Number: 19933612
• Product Code: MCX
• UDI-Device Identifier: 08714729975076
• UDI-Public: (01)08714729975076
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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: Health Professional
• Device Model Number: 3256
• Device Catalogue Number: 3256
• Device Lot Number: RP006834
• 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: 02/04/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown