MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RotaLink Plus; catheter, coronary, atherectomy

Model Number	H749236310020
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that brake malfunction occurred.The target lesion was located in the right coronary artery.A 1.25mm rotablator rotalink plus was selected for use.While preparing the device, outside the patient, it was noted that the brake of the device was broken.The procedure was completed using another of the same device.No complications were reported, and patient is stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).

• Brand Name: RotaLink Plus
• 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(612)875-7234
• MDR Report Key: 21426529
• Report Number: 2124215-2025-07757
• Device Sequence Number: 7642555
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: 08714729316411
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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 Expiration Date: 11/19/2024
• Device Model Number: H749236310020
• Device Catalogue Number: H749236310020
• Device Lot Number: 0030743158
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2026
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• 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