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

Model Number	2077-01
Medical Device Problem Codes	Nonstandard Device (1420); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Perforation (2001); Foreign Body In Patient (2687)
Date of Event	04/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) medical center.
Event or Problem Description
It was reported that the wire tip was separated and caused perforation.The 18 mm severely calcified target lesion was located in the proximal right coronary artery with a vessel diameter of 3.00 mm.A 1.50 mm rotapro and a rotawire drive were selected for use.The devices were used to ablate the lesion approximately 10 times at 180,000 rpm for 15-20 seconds each.During ablation, due to contact with the burr, the proximal portion of the wire separated and remained in the body when the system was removed.A vessel wall perforation was noted and a non-scientific balloon was used to control the bleeding.Attempts made to retrieve the detached wire were unsuccessful and the fragment was secured with a stent.Per the assessment of the physician, the separation was considered to be more related to the case and the operator's technique, rather than a product defect.The perforation was due to a proximal vessel bend of less than 90 degrees.The vessel also maintained its shape and failed to stretch during rotablation.The procedure was completed with this device with no further 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: 25243951
• Report Number: 2124215-2026-27450
• Device Sequence Number: 21466218
• Product Code: MCX
• UDI-Device Identifier: 08714729996262
• UDI-Public: (01)08714729996262(17)270616(10)36770518
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2077-01
• Device Catalogue Number: 2077-01
• Device Lot Number: 0036770518
• 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: 04/24/2026
• Supplement Date Received by Manufacturer: 06/07/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown