MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE? AND WIRECLIP? TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number	H802228240020
Medical Device Problem Codes	Entrapment of Device (1212); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that rotalink burr got stuck with the rotawire.A 1.25 mm rotablator rotalink plus burr and rotawire were selected for use.During the procedure, the burr was jammed and could not be advanced.When attempting to remove the rotawire, it became stuck with the burr.The procedure was completed using an alternate device.There were no complications, and patient fully recovered.
Additional Manufacturer Narrative
B3 date of event: used the first day of the month of the bsc aware date as the event date was not provided.

• 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 ; 7634941632
• MDR Report Key: 25595762
• Report Number: 2124215-2026-33371
• Device Sequence Number: 12107939
• Product Code: MCX
• UDI-Device Identifier: 08714729185871
• UDI-Public: (01)08714729185871(17)250102(10)30779361
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2026

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: Other
• Device Expiration Date: 01/02/2025
• Device Model Number: H802228240020
• Device Catalogue Number: H802228240020
• Device Lot Number: 0030779361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 06/23/2026
• Supplement Report FDA Received Date: 07/20/2026
• Date Device Manufactured: 01/03/2023
• 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