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

Model Number	H749394671250
Medical Device Problem Codes	Nonstandard Device (1420); Self-Activation or Keying (1557); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: the event date was note reported.The first date of the month of the aware date was entered as an estimate.
Event or Problem Description
It was reported that an unintentional switch to dynaglide mode occurred.A 1.25 mm rotapro burr was selected for the procedure.During angioplasty of the left anterior descending (lad) artery, the device unintentionally switched to dynaglide mode.The mode did not deactivate automatically when pressing the dynaglide mode button.No patient complications occurred.
Event or Problem Description
It was reported that an unintentional switch to dynaglide mode occurred.A 1.25 mm rotapro burr was selected for the procedure.During angioplasty of the left anterior descending (lad) artery, the device unintentionally switched to dynaglide mode.The mode did not deactivate automatically when pressing the dynaglide mode button.No patient complications occurred.
Additional Manufacturer Narrative
B3: date of event: the event date was note reported.The first date of the month of the aware date was entered as an estimate.Investigation results: device history review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Device technical analysis: returned product consisted of the rotapro atherectomy system.Visual inspection of the device did not identify any damages or defects.When the rotapro system was connected to the rotapro console and the ablation button was pressed, the device stalled and did not run.During the stall, the device was able to change between dynaglide mode and normal mode without issue or resistance.Dynaglide was turned on and off without issue or resistance.In order to determine the reason for the device stall, the advancer was dismantled and the components inside the advancer were inspected.After destructive testing was performed, it was found that the drive shaft (turbine) was corroded, indicating the presence of dried saline within the device.Product analysis did not confirm the reported unintentional mode change as clinical circumstances could not be replicated.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: this product investigation is assigned the most probable cause classification of adverse event related to procedure.It was considered likely that the reported unintentional mode switching and the condition of the returned device occurred due to procedural factors which can include device interaction and testing.

• 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; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24366768
• Report Number: 2124215-2026-08850
• Device Sequence Number: 17450038
• Product Code: MCX
• UDI-Device Identifier: 08714729999560
• UDI-Public: (01)08714729999560(17)271204(10)38110609
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P900056
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2026

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: H749394671250
• Device Catalogue Number: H749394671250
• Device Lot Number: 0038110609
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 04/17/2026; 05/07/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 05/04/2026; 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown