MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE Drive; catheter, coronary, atherectomy

Model Number	2077-01
Medical Device Problem Codes	Nonstandard Device (1420); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the wire distal tip was separated.A 1.50mm rotapro and a rotawire drive were selected for use in the severely calcified right coronary artery.During the procedure, it was noted that the wire was bent and the distal tip separated due to contact with the burr.The device fragment was entangled with a wire and removed.The procedure was completed with another of the same device.There were no patient complications, and the patient fully recovered after the procedure.

• Brand Name: ROTAWIRE Drive
• 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; 302 parkway, global park; la aurora - heredia, ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 50102938
• Report Number: 2124215-2026-41307
• Device Sequence Number: 5305409
• Product Code: MCX
• UDI-Device Identifier: 08714729996262
• UDI-Public: (01)08714729996262(17)270506(10)36455829
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2026

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 Model Number: 2077-01
• Device Catalogue Number: 2077-01
• Device Lot Number: 0036455829
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Guide Catheter: Asahi Intecc Hyperion
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown