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

Model Number	H749236310020
Medical Device Problem Codes	Nonstandard Device (1420); Material Separation (1562); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter address 1: (b)(6) hospital.E1 initial reporter phone: (b)(6).
Event or Problem Description
It was reported that burr fracture occurred.The 80% target lesion was located in the mildly tortuous and severely calcified circumflex branch.A 1.25mm rotablator plus was selected for use.During procedure, it was noted that the burr made an abnormal sound, and after it was withdrawn from the body, the burr was fractured and only a wire of connection was left.The device was simply removed.The procedure was completed with another of the same device.There were no patient complications and patient was stable post procedure.
Additional Manufacturer Narrative
E1 initial reporter address 1: (b)(6).E1 initial reporter phone: (b)(6).Investigation results: device analysis findings: device evaluated by manufacturer: the device was returned for analysis.Visual inspection found that the coil was stretched from the handshake connection to the distal end of the coil.The coil was detached at the distal end (burr end) of the device.Media provided by the customer shows the distal portion of the burr catheter.The rotawire is visibly in place within the device containing both the burr catheter and the burr, a detachment to the coil and burr is visible, and the coil also appears to be stretched just proximal to the detachment.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.Investigation conclusion: the most probable cause for this complaint was considered adverse event related to procedure.It was considered likely that the reported events and the condition of the returned device occurred due to factors encountered during the procedure as the reported events indicate that the issue occurred during procedural use while inside the patient when the console was started.This indicates that draw testing was successful.Based on the reported information, it was not able to be determined if the severity of the target lesion was a contributing factor to the reported events.
Event or Problem Description
It was reported that burr fracture occurred.The 80% target lesion was located in the mildly tortuous and severely calcified circumflex branch.A 1.25mm rotablator plus was selected for use.During procedure, it was noted that the burr made an abnormal sound, and after it was withdrawn from the body, the burr was fractured and only a wire of connection was left.The device was simply removed.The procedure was completed with another of the same device.There were no patient 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: 24380545
• Report Number: 2124215-2026-09155
• Device Sequence Number: 16081679
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: (01)08714729316411(17)270723(10)37273811
• 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): 04/21/2026

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: 0037273811
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2025
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 50 KG