MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE Drive; catheter, coronary, atherectomy

Model Number	2077-02
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	07/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the wire detached and a perforation occurred requiring additional surgery.The 15mm long and 95% stenosed target lesion was located in the severely tortuous and severely calcified mid left anterior descending artery with a vessel diameter of 3.0 mm.A 1.25mm rotapro and rotawire drive were selected for use.During the procedure, difficulty crossing the lesion was experienced.Seventeen ablations were performed at a set speed of 190,000 rpm for 15 seconds each.The physician noted reductions in speed ranging from 2,000 to 10,000 rpm during ablation.A perforation was observed on the opposite side of the calcified nodule and upon withdrawal of the devices it was noted that the rotawire had separated a few centimeters proximal to the radiopaque marker.It was considered possible that the separation was due to burr contact.Bypass grafting of the proximal lad was performed to treat the perforation.No device fragments were left inside the body.Following surgery, the patient was weaned from mechanical ventilation, resumed oral intake, and is currently undergoing rehabilitation.
Additional Manufacturer Narrative
A4 weight: (b)(6).

• 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 ; +1(612)875-7234
• MDR Report Key: 50735310
• Report Number: 2124215-2026-48727
• Device Sequence Number: 16117829
• Product Code: MCX
• UDI-Device Identifier: 08714729996248
• UDI-Public: (01)08714729996248(17)270722(10)37025680
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: 2077-02
• Device Catalogue Number: 2077-02
• Device Lot Number: 0037025680
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2025
• 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
• Patient Age: 88 YR
• Patient Sex: Male