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

Model Number	H749236310020
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that failure to lock on wire occurred.The 90% stenosed, 32 mm long target lesion was located in the moderately tortuous and severely calcified left anterior descending artery with a vessel diameter pf 3.5 mm.A 1.25mm rotablator plus and rotawire were selected for use.During procedure, it was noted that after the burr stopped rotating at a low speed upon reaching 1-2cm from the lesion site, the guide wire moved backward with unknown reasons.The device was replaced.The procedure was completed with another of the same device.There were no patient complications, and the patient condition was stable post procedure.

• 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; business and technology park,; 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: 50181030
• Report Number: 2124215-2026-42520
• Device Sequence Number: 18210399
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: (01)08714729316411(17)280113(10)38584415
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/07/2026

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: H749236310020
• Device Catalogue Number: H749236310020
• Device Lot Number: 0038584415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 08/07/2026
• Date Device Manufactured: 02/12/2026
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Weight: 176 LB