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

Model Number	3320
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.(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 burr was stuck in the lesion.The target lesion was located in the left anterior descending artery.A 1.25mm rotalink burr was selected for use.During the procedure, the burr catheter got stuck when crossing the lesion and could not be smoothly crossed.Therefore, the burr was replaced, and the procedure was successfully completed with another of the same device.There were no patient complications, and the patient was stable post procedure.
Additional Manufacturer Narrative
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 device - difficult/unable to advance 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: 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.Therefore, based on a thorough review of the device history record (dhr) and reported complaint, the most probable cause for this complaint was considered adverse event related to procedure.
Event or Problem Description
It was reported that the burr was stuck in the lesion.The target lesion was located in the left anterior descending artery.A 1.25mm rotalink burr was selected for use.During the procedure, the burr catheter got stuck when crossing the lesion and could not be smoothly crossed.Therefore, the burr was replaced, and the procedure was successfully completed with another of the same device.There were no patient complications, and the patient was stable post procedure.It was further reported that 90% stenosed target lesion was located in the mildly tortuous and mildly calcified.And also confirmed, that the issue reported that the burr was not actually stuck within the lesion, rather the burr catheter was difficult to advance.The device was removed from the patient in simply pulled out.

• Brand Name: ROTALINK BURR
• 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: 24554641
• Report Number: 2124215-2026-13073
• Device Sequence Number: 15668484
• Product Code: MCX
• UDI-Device Identifier: 08714729185864
• UDI-Public: (01)08714729185864(17)270610(10)36722106
• 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): 04/09/2026

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: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0036722106
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/09/2026
• Date Device Manufactured: 06/10/2025
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 60 KG