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

Model Number	H749236310030
Medical Device Problem Codes	Nonstandard Device (1420); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction

• 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: 50903109
• Report Number: 2124215-2026-51277
• Device Sequence Number: 21510931
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: (01)08714729228363(17)261104(10)35416283
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 09/25/2026

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: H749236310030
• Device Catalogue Number: H749236310030
• Device Lot Number: 0035416283
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• 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