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

Model Number	29710
Medical Device Problem Codes	Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulty occurred.A peripheral rotawire guidewire was selected for use.During the procedure, the rotawire was delivered through the rubicon catheter.There was a resistance exchanging the wire.There were no patient complications.
Event or Problem Description
It was reported that removal difficulty occurred.A peripheral rotawire guidewire was selected for use.During the procedure, the rotawire was delivered through the rubicon catheter.There was a resistance exchanging the wire.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by manufacturer.The complaint device was received for product analysis.A visual examination identified kinks on the body of the wire from distal to proximal with the following measurements, 17.0 inches, 68.0 inches and 102.0 inches.A microscopic inspection identified a bent spring tip.No other issues were identified during the product analysis.

• Brand Name: PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER
• Common Device Name: CATHETER, PERIPHERAL, 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 CA 95134
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23234500
• Report Number: 2124215-2025-70681
• Device Sequence Number: 9774854
• Product Code: MCW
• UDI-Device Identifier: 08714729863649
• UDI-Public: (01)08714729863649(17)270226(10)35950023
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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 Model Number: 29710
• Device Catalogue Number: 29710
• Device Lot Number: 0035950023
• 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: 09/15/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 10/07/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2025
• 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