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

Model Number	2077-01
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr was stuck on the wire.A 1.75mm rotapro and rotawire drive were selected for use.During the procedure, the wire and the burr got stuck.The burr was removed together with the wire.The procedure was completed with another of same device.There were no patient complications were 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50546938
• Report Number: 2124215-2026-45878
• Device Sequence Number: 10318045
• Product Code: MCX
• UDI-Device Identifier: 08714729996262
• UDI-Public: (01)08714729996262(17)280127(10)38433442
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: 0038433442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2026
• Supplement Date Received by Manufacturer: 08/29/2026
• Initial Report FDA Received Date: 09/01/2026
• Supplement Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 01/27/2026
• 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