MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE DRIVE; CATHETER, CORONARY, ATHERECTOMY

Model Number	2077-01
Medical Device Problem Codes	Entrapment of Device (1212); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr became stuck with the guidewire.The 75% stenosed target lesion was located in a moderately tortuous and severely calcified artery.A 1.75mm rotapro and a rotawire drive were selected for use.During insertion, the rotaburr became stuck on the rotawire and could not be released from being stuck.The rotaburr was removed together with the rotawire from the body as one unit.The procedure was completed with another of the same device.There were no patient complications reported.

• 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 ; 7634941632
• MDR Report Key: 25058327
• Report Number: 2124215-2026-23808
• Device Sequence Number: 9353688
• Product Code: MCX
• UDI-Device Identifier: 08714729996262
• UDI-Public: (01)08714729996262(17)270514(10)36521135
• 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): 07/07/2026

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: 2077-01
• Device Catalogue Number: 2077-01
• Device Lot Number: 0036521135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2025
• 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