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

Model Number	H749236310020
Medical Device Problem Codes	Entrapment of Device (1212); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that rotaburr was stuck with the rotawire.The target lesion was located in the left coronary artery.A 1.50mm rotapro and rotawire were selected for use.During the procedure, it was reported that the rotawire was stuck with the rotaburr and fractured.The procedure was completed using another of the same device.There were no complications, and patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).
Additional Manufacturer Narrative
(b)(6).Investigation results: device analysis findings: device evaluated by manufacturer.The complaint device was received for product analysis.A visual inspection of the device did not reveal any damages or defects.Microscopic inspection of the device revealed that the annulus of the burr was damaged not rounded.The damage to the annulus was found to be consistent with continuous interaction between the rotating burr and the rotawire.No other issues were identified during the product analysis.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: a risk review was completed and confirmed that the events of burr stuck on wire and guidewire fracture were 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 reported complaint, the most probable cause for this complaint was considered adverse event related to procedure.It was considered likely that the reported events occurred due to factors encountered during the procedure, such as continuous interaction between the rotating burr and the rotawire at a single point of the rotawire, leading to resistance and wire fracture.
Event or Problem Description
It was reported that rotaburr was stuck with the rotawire.The target lesion was located in the left coronary artery.A 1.50mm rotapro and rotawire were selected for use.During the procedure, it was reported that the rotawire was stuck with the rotaburr and fractured.The procedure was completed using another of the same device.There were no complications, and 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: 23032029
• Report Number: 2124215-2025-62855
• Device Sequence Number: 9181523
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: (01)08714729316411(17)260122(10)33481509
• 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): 03/11/2026

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: 01/22/2026
• Device Model Number: H749236310020
• Device Catalogue Number: H749236310020
• Device Lot Number: 0033481509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Weight: 70 KG