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

Model Number	H749394672000
Medical Device Problem Codes	Nonstandard Device (1420); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2.Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the burr got detached.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left circumflex ostium.A 2.00mm rotapro was selected for use.During the procedure, the rotation speed was set to 180,000 rpm.When the third debulking performed, it was noted that the rotating burr did not move and got separated.Since the detached burr was on the rotawire drive, it was simply removed outside the body along with the wire.The procedure was completed without patient complications reported.
Additional Manufacturer Narrative
A2.Age at time of event: 18 years or older.Investigation results: device analysis findings: device evaluated by manufacturer.The complaint device was received for product analysis.A visual inspection of the device found that the burr was detached and returned on the returned rotawire.The burr was able to be removed from the wire with no resistance or issue.Majority of the coil was found to be stretched from the handshake to the distal end of the coil, which was detached.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.Device history review (dhr): 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.Investigation conclusion: the most probable cause for this complaint was considered adverse event related to procedure.It was considered likely that the reported events and the condition of the returned device occurred due to factors encountered during the procedure as the reported events indicate that the issue occurred during ablation.
Event or Problem Description
It was reported that the burr got detached.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left circumflex ostium.A 2.00mm rotapro was selected for use.During the procedure, the rotation speed was set to 180,000 rpm.When the third debulking performed, it was noted that the rotating burr did not move and got separated.Since the detached burr was on the rotawire drive, it was simply removed outside the body along with the wire.The procedure was completed without patient complications reported.

• 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: 23820690
• Report Number: 2124215-2025-91177
• Device Sequence Number: 15805088
• Product Code: MCX
• UDI-Device Identifier: 08714729999591
• UDI-Public: (01)08714729999591(17)260320(10)33672700
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 03/20/2026
• Device Model Number: H749394672000
• Device Catalogue Number: H749394672000
• Device Lot Number: 0033672700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2024
• 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