MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK? PLUS; CATHETER, CORONARY, ATHERECTOMY

Model Number	H749236310030
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that unstable speed occurred.The target lesion was located in the left main trunk artery.A 1.50mm rotablator plus was selected for percutaneous coronary intervention (pci).During the procedure, inside the patient, it was noted that the device could not switch between the high and low speed.There were no patient complications, and the patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) e1 initial reporter phone: (b)(6).Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.\ risk review if completed: a risk review was completed and confirmed that the event of unstable speed was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the device history record and reported complaint, the most probable cause for this complaint was considered adverse event related to procedure.As the reported events do not indicate any device damages or failures during unpackaging, preparation, or testing, it was considered likely that the reported events occurred due to factors encountered during the procedure.
Event or Problem Description
It was reported that unstable speed occurred.The target lesion was located in the left main trunk artery.A 1.50mm rotablator plus was selected for percutaneous coronary intervention (pci).During the procedure, inside the patient, it was noted that the device could not switch between the high and low speed.There were no patient complications, and the patient 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; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24416516
• Report Number: 2124215-2026-09861
• Device Sequence Number: 18792951
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: (01)08714729228363(17)270308(10)36245347
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 04/06/2026

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: 0036245347
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 04/06/2026
• Date Device Manufactured: 04/07/2025
• 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
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 65 KG