MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO?; catheter, coronary, atherectomy

Model Number	H749394671750
Medical Device Problem Codes	Entrapment of Device (1212); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter address 1: (b)(6).E1 initial reporter city: (b)(6).
Event or Problem Description
It was reported that burr stuck on wire occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified mid-proximal right coronary artery.A 1.75mm rotapro and rotawire was selected for use.During insertion inside the patient, speed reached 185,000 rpm despite a setting of 190,000 rpm.It was noted that the rota burr got stuck with the rotawire and was unable to released.The devices were removed together from the patient.The procedure was completed with another of the same device.There were no patient complications.

• Brand Name: ROTAPRO?
• 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; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 25682419
• Report Number: 2124215-2026-35209
• Device Sequence Number: 13175778
• Product Code: MCX
• UDI-Device Identifier: 08714729999584
• UDI-Public: (01)08714729999584(17)280226(10)38701408
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2026

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: H749394671750
• Device Catalogue Number: H749394671750
• Device Lot Number: 0038701408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Supplement Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 07/01/2026
• Supplement Report FDA Received Date: 08/05/2026
• Date Device Manufactured: 02/26/2026
• 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