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

Model Number	3320
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Detachment of Device or Device Component (2907); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter phone: (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 catheter was fractured.The target lesion was located in the coronary artery.A 1.25mm rotalink burr was selected for use.During the procedure, the burr catheter got fractured.The procedure was completed with another of the same device.There were no complications reported, and the patient was good and stable post procedure.
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the burr catheter was fractured.The target lesion was located in the coronary artery.A 1.25mm rotalink burr was selected for use.During the procedure, the burr catheter got fractured.The procedure was completed with another of the same device.There were no complications reported, and the patient was good and stable post procedure.It was further reported that the 90% stenosed target lesion was located in the mildly tortuous and severely calcified artery.During the procedure, the burr also stuck from the lesion.It was thought that the speed was lower than intended and stuck was noticed.The catheter was removed normally and completed the procedure.
Event or Problem Description
It was reported that the burr catheter was fractured.The target lesion was located in the coronary artery.A 1.25mm rotalink burr was selected for use.During the procedure, the burr catheter got fractured.The procedure was completed with another of the same device.There were no complications reported, and the patient was good and stable post procedure.It was further reported that the 90% stenosed target lesion was located in the mildly tortuous and severely calcified artery.During the procedure, the burr also stuck from the lesion.It was thought that the speed was lower than intended and stuck was noticed.The catheter was removed normally and completed the procedure.
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).H6 device codes: updated.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual and microscope inspection of the device did not identify any damages or defects.The returned burr catheter and a test advancer were connected to which was then connected to the rotablator console control system to test for rotation.When the foot pedal was pushed, the device was able to reach and maintain optimal speed without issue or resistance.E1 initial reporter phone: (b)(6).H6 device codes: updated.
Event or Problem Description
It was reported that the burr catheter was fractured.The target lesion was located in the coronary artery.A 1.25mm rotalink burr was selected for use.During the procedure, the burr catheter got fractured.The procedure was completed with another of the same device.There were no complications reported, and the patient was good and stable post procedure.It was further reported that the 90% stenosed target lesion was located in the mildly tortuous and severely calcified artery.During the procedure, the burr also stuck from the lesion.It was thought that the speed was lower than intended and stuck was noticed.The catheter was removed normally and completed the procedure.

• 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: 22834521
• Report Number: 2124215-2025-57198
• Device Sequence Number: 15810259
• Product Code: MCX
• UDI-Device Identifier: 08714729185864
• UDI-Public: (01)08714729185864(17)260424(10)33895443
• 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,Followup,Followup
• Report Date (Section B): 11/19/2025

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: 04/24/2026
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0033895443
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 08/15/2025; 10/09/2025; 11/04/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 09/06/2025; 11/03/2025; 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• 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: 77 YR
• Patient Sex: Female
• Patient Weight: 53 KG