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

Model Number	2077-02
Medical Device Problem Codes	Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device contamination occurred.The target lesion was located in the coronary artery.Five rotawire drive wires were selected for rotablation.During insertion, excessive coating was observed on the wires, causing the rotawire adhere to the burr.In dynaglide mode, the wire was unable to advance normally.It was later noted that the first wire had accumulated multiple fibers from the drape, forming a ball of fluff that advanced toward the coronary artery.Attempts to use the remaining four wires yielded similar results.The final wire seized within the burr, appearing to have fibers adhered to it as if by glue.Despite multiple attempts to clean the wire, including wiping it end-to-end approximately ten times and manually removing the lumps, the wire remained sticky and unusable.The procedure was prolonged but ultimately completed with a another rotawire device.There were no patient complications.

• 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: 23568166
• Report Number: 2124215-2025-83386
• Device Sequence Number: 18672007
• Product Code: MCX
• UDI-Device Identifier: 08714729996248
• UDI-Public: (01)08714729996248(17)260926(10)34938991
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2025

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: 09/26/2026
• Device Model Number: 2077-02
• Device Catalogue Number: 2077-02
• Device Lot Number: 0034938991
• 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: 10/22/2025
• Initial Report FDA Received Date: 11/17/2025
• Date Device Manufactured: 09/26/2024
• 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