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

Model Number	H749236310040
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).Good faith effort attempts were made to try and confirm device return and additional detail about what "break" means, but it was unable to be obtained.
Event or Problem Description
It was reported that a burr broke.The target lesion was located in the moderately tortuous and moderately calcified artery.A 1.75mm rotablator rotalink plus was selected for use.During pre-testing, it was normal to increase the speed; however, after using the device, it was noted that the front of the burr broke.The device was removed all system as usual step.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.
Event or Problem Description
It was reported that a burr broke.The target lesion was located in the moderately tortuous and moderately calcified artery.A 1.75mm rotablator rotalink plus was selected for use.During pre-testing, it was normal to increase the speed; however, after using the device, it was noted that the front of the burr broke.The device was removed all system as usual step.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).Device evaluated by manufacturer: the burr catheter returned connected to the advancer.The burr was found to be detached.The related rotawire returned within the rotablator plus system, contained the detached burr.Microscope inspection of the device found no damage or irregularity.Visual inspection on device found that the burr and coil were detached.The burr was detached and was found returned on the returned rotawire.The rotawire was removed from the rotablator plus system with resistance due to kinks present on the wire and the nature of the coil detachment.The burr was removed with resistance due to the wire damage present.

• 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: 21874464
• Report Number: 2124215-2025-24779
• Device Sequence Number: 8640963
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: (01)08714729228370(17)250610(10)31986668
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2025

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: 06/10/2025
• Device Model Number: H749236310040
• Device Catalogue Number: H749236310040
• Device Lot Number: 0031986668
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• 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 Sex: Unknown