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

Model Number	H749394671750
Medical Device Problem Codes	Output Problem (3005); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that unstable speed occurred.The target lesion was located in the coronary artery.A rotapro 1.75mm was selected for use.During rotation in the high-speed mode, it was noted that although the set rotational speed was 140,000, the maximum rotational speed was found to be 160,000 rpm.Additionally, it was noted that during rotational grinding a stall occurred.The procedure was completed with another of the same device.There were no patient complications, and the patient was stable post procedure.
Additional Manufacturer Narrative
E1(b)(6).

• 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: 24268981
• Report Number: 2124215-2026-06580
• Device Sequence Number: 21513527
• Product Code: MCX
• UDI-Device Identifier: 08714729999584
• UDI-Public: (01)08714729999584(17)270424(10)36363506
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/05/2026

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: H749394671750
• Device Catalogue Number: H749394671750
• Device Lot Number: 0036363506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 02/05/2026
• Date Device Manufactured: 04/24/2025
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Weight: 81 KG