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

Model Number	H749236310040
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter address: (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.
Event or Problem Description
It was reported that the labelling was incorrect.The target lesion was located in the anterior descending branch.A 1.75mm rotablator rotalink plus was selected for coronary artery stent implantation.During procedure, it was found that the burr was too small.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable following the procedure.
Additional Manufacturer Narrative
E1: (b)(6).Corrected h6.Device code investigation results: media review: a photo of product packaging and documentation were attached to the complaint record, but no evidence of the reported events was present within the attached photo.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: a risk review was completed and confirmed that the event of device exchange required [user preference issue (burr too small)] 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 dhr 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 are not a fault of the device as exchanging of the burr catheter is an anticipated part of the procedure and is documented within the device instruction for use (ifu) and no other device malfunctions were reported.It was considered likely that the reported events were attributable to other procedural factors.
Event or Problem Description
It was reported that the labelling was incorrect.The target lesion was located in the anterior descending branch.A 1.75mm rotablator rotalink plus was selected for coronary artery stent implantation.During procedure, it was found that the burr was too small.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable following the 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: 24071396
• Report Number: 2124215-2026-02548
• Device Sequence Number: 9130285
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: (01)08714729228370(17)270429(10)36631628
• 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): 03/26/2026

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: H749236310040
• Device Catalogue Number: H749236310040
• Device Lot Number: 0036631628
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 03/26/2026
• Date Device Manufactured: 05/29/2025
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 47 KG