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

Model Number	H749394671250
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It wait was reported that the burr was stuck in the lesion.A rotapro 1.25mm was selected for treatment of the target lesion.After introducing the burr to the target lesion, the physician noticed a stuck indication.They removed the device from the patient and used another of the same device to successfully complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
The device was not returned to the complaint investigation site for analysis.The instructions for use include testing of the device before usage within the body and state that use of the device is to be discontinued if evidence of a failure or damage is present.As the reported events do not indicate any device damages or failures during unpackaging, preparation, or testing, it was considered likely that the reported events occurred due to factors encountered during the procedure.Therefore, based on a thorough review of the device history record and reported complaint, the most probable cause for this complaint was considered adverse event related to procedure.
Event or Problem Description
It wait was reported that the burr was stuck in the lesion.A rotapro 1.25mm was selected for treatment of the target lesion.After introducing the burr to the target lesion, the physician noticed a stuck indication.They removed the device from the patient and used another of the same device to successfully complete the procedure.There were no patient complications.

• 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: 24650620
• Report Number: 2124215-2026-15534
• Device Sequence Number: 9760753
• Product Code: MCX
• UDI-Device Identifier: 08714729999560
• UDI-Public: (01)08714729999560(17)260723(10)34488990
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/23/2026

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 Expiration Date: 07/23/2026
• Device Model Number: H749394671250
• Device Catalogue Number: H749394671250
• Device Lot Number: 0034488990
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2024
• 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