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

Model Number	H74939462001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the rotawire fractured and retained inside the patient.The greater than 80% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery.A rotawire drive was selected for use.During procedure, it was noted that after the removal of rotalink plus 1.50mm, a portion of the radiopaque tip about 0.014 inches of the rotawire drive floppy was fractured in the distal part.The physician chose to leave the fragment in the patient, since it was in a distal branch with no risk of complication.There were no patient complications, and the patient was expected to fully recover.

• Brand Name: ROTAWIRE? DRIVE 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: 25452704
• Report Number: 2124215-2026-30894
• Device Sequence Number: 10363107
• Product Code: MCX
• UDI-Device Identifier: 08714729996255
• UDI-Public: (01)08714729996255(17)270607(10)36704461
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2026

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: H74939462001
• Device Catalogue Number: H74939462001
• Device Lot Number: 0036704461
• 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: 05/25/2026
• Supplement Date Received by Manufacturer: 06/25/2026
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 07/14/2026
• Date Device Manufactured: 06/07/2025
• 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 Age: 65 YR
• Patient Sex: Female
• Patient Weight: 130 KG