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

Model Number	H749394672000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the burr got detached.A 2.00mm rotapro was selected for use.During the procedure, after cutting the shaft, it was attempted to remove the stuck device by bringing in a guide extension, but only the shaft came out.Consequently, during debulking of the right shoulder region, the burr was found detached which was likely due to hinge motion.The burr was retrieved along with the rota wire.The procedure was completed.There was no patient injury.
Event or Problem Description
It was reported that the burr got detached.A 2.00 mm rotapro was selected for use.During the procedure, after cutting the shaft, it was attempted to remove the stuck device by bringing in a guide extension, but only the shaft came out.Consequently, during debulking of the right shoulder region, the burr was found detached which was likely due to hinge motion.The burr was retrieved along with the rota wire.The procedure was completed.There was no patient injury.
Additional Manufacturer Narrative
B1: adverse event/product problem: corrected.H1: type of reportable event: corrected.H6: impact codes: corrected.Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the device found that the returned fractured rotawire, which contained the detached rotapro burr, was able to be removed from the guideliner.The burr was free moving and was able to be removed from the wire portion without issue or resistance.

• 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: 23062621
• Report Number: 2124215-2025-64782
• Device Sequence Number: 9662673
• Product Code: MCX
• UDI-Device Identifier: 08714729999591
• UDI-Public: (01)08714729999591(17)260530(10)34138708
• 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): 11/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2026
• Device Model Number: H749394672000
• Device Catalogue Number: H749394672000
• Device Lot Number: 0034138708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown