MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO?; catheter, coronary, atherectomy

Model Number	H749394671250
Medical Device Problem Codes	Nonstandard Device (1420); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that burr detachment occurred.A 1.35mm rotapro was selected for use.During procedure, the burr disconnected inside the patient.The procedure was completed with another of the different device.There were no patient complications.
Event or Problem Description
It was reported that burr detachment occurred.A 1.35mm rotapro was selected for use.During procedure, the burr disconnected inside the patient.The procedure was completed with another of the different device.There were no patient complications.
Additional Manufacturer Narrative
With all the available information, boston scientific concludes: device history record review: the device history record review confirmed that the device met all material, assembly, and performance specifications prior to distribution.Device technical analysis: the returned device consisted of the rotapro atherectomy system.Inspection of the device showed that the rotawire was able to be removed with no issue.The distal portion of the handshake connection to the burr catheter, which was within the sheath and retrievable upon device return, was found to be detached at the drive interlock weld component and was slightly bent.Additionally, there were multiple sheath kinks to the device.Labeling review: based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.Risk review: a review of the rotapro hazard analysis was completed and confirmed that the event of burr detachment of device or device component was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: it was considered likely that the reported events and the condition of the returned device occurred due to procedural factors which can include device interaction and handling.Based on a thorough review of the reported complaint, the most probable cause for this complaint was considered adverse event related to 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; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25541732
• Report Number: 2124215-2026-32510
• Device Sequence Number: 18435489
• Product Code: MCX
• UDI-Device Identifier: 08714729999560
• UDI-Public: (01)08714729999560(17)270522(10)36583296
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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: 0036583296
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/22/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 06/17/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• 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