MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RotaWire? and wireClip? Torquer; catheter, coronary, atherectomy

Model Number	H802228240020
Medical Device Problem Codes	Fracture (1260); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a guidewire fracture occurred.A rotawire-ic was selected for use and positioned in the target artery for treatment with the rotablator system.During the draw test, as the guidewire was advanced through the device catheter specifically in the region near the introducer, it was noted that the guidewire fractured.As a result, one portion of the guidewire remained inside the patient, while the other portion remained outside, within the rotablator catheter.The guidewire was immediately replaced with another of the same device, and the procedure was successfully completed.There were no adverse effects on the patient.

• Brand Name: RotaWire? and wireClip? Torquer
• 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(612)875-7234
• MDR Report Key: 25084078
• Report Number: 2124215-2026-24231
• Device Sequence Number: 10433475
• Product Code: MCX
• UDI-Device Identifier: 08714729185871
• UDI-Public: (01)08714729185871(17)260919(10)34886962
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2026

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 Expiration Date: 09/19/2026
• Device Model Number: H802228240020
• Device Catalogue Number: H802228240020
• Device Lot Number: 0034886962
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Supplement Date Received by Manufacturer: 05/18/2026; 09/02/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 06/05/2026; 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2024
• 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 Age: 87 YR
• Patient Sex: Female
• Patient Weight: 165 LB