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

Model Number	H749394672000
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that brake failure occurred.The target lesion was located in the moderately tortuous and moderately calcified left circumflex artery.A 2.00mm rotapro and rotawire were selected for use.During the procedure, the burr was advanced in dynaglide mode, and an attempt was made to start at 180,000 rpm, but brake failure has occurred and the rotawire came out from the inserted position.It was tried three times, but the situation was the same, so the advancer was replaced.The device was removed normally and the procedure was completed with another of the same device.There was no patient injury.
Event or Problem Description
It was reported that brake failure occurred.The target lesion was located in the moderately tortuous and moderately calcified left circumflex artery.A 2.00mm rotapro and rotawire were selected for use.During the procedure, the burr was advanced in dynaglide mode, and an attempt was made to start at 180,000 rpm, but brake failure has occurred and the rotawire came out from the inserted position.It was tried three times, but the situation was the same, so the advancer was replaced.The device was removed normally and the procedure was completed with another of the same device.There was no patient injury.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the device did not identify any damages or defects.Inspection of the device after destructive testing found that the driveshaft (turbine) was corroded.As the rotawire used in the procedure was not returned, a test rotawire was used for analysis.During analysis, the test rotawire was able to be fully inserted and removed from the device with no resistance or issues.When the rotapro system was connected to the rotapro console, the ablation button was pressed, the device stalled and did not run.Despite device stall during analysis, the brake defeat button was pushed, and the brake was able to engage and disengage properly with the wire 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.

• 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: 23351077
• Report Number: 2124215-2025-73523
• Device Sequence Number: 21034377
• Product Code: MCX
• UDI-Device Identifier: 08714729999591
• UDI-Public: (01)08714729999591(17)270815(10)37219037
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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: H749394672000
• Device Catalogue Number: H749394672000
• Device Lot Number: 0037219037
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2025
• 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