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

Model Number	H749236310030
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a guidewire fracture occurred.The target lesion was located in the anterior descending artery, a 1.50 mm rotablator plus and rotawire: ic were selected for use.During the procedure, the guidewire was fractured, resulting in the scrapping of the device.The device was removed, and the procedure was 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).Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the burr and guidewire fracture occurred.The target lesion was located in the anterior descending artery, a 1.50mm rotablator plus and rotawire - ic were selected for use.During the procedure, the rotational atherectomy guidewire was fractured, resulting in the scrapping of the device.The device was removed, and the procedure was completed with another of the same device.There were no patient complications, and the patient was stable post procedure.It was further reported that the 90% stenosed target lesion was located in a moderately tortuous and moderately calcified artery, and the burr caused the guidewire to fracture.The guidewire fragment was not removed from the body.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Device evaluated by manufacturer: the complaint device was received for product analysis.A visual inspection of the device did not identify any damages or defects.As the rotawire used in the procedure was not returned with the rotapro, a test rotawire was used for analysis.During analysis, the test rotawire was able to be fully inserted and removed from the device with no resistance or issues.A media inspection depicts a portion of outer box packaging to the reported rotablator plus batch, and another non-bsc outer box.No evidence of the reported event was provided.
Event or Problem Description
It was reported that the burr and guidewire fracture occurred.The target lesion was located in the anterior descending artery, a 1.50mm rotablator plus and rotawire - ic were selected for use.During the procedure, the rotational atherectomy guidewire was fractured, resulting in the scrapping of the device.The device was removed, and the procedure was completed with another of the same device.There were no patient complications, and the patient was stable post procedure.It was further reported that the 90% stenosed target lesion was located in a moderately tortuous and moderately calcified artery, and the burr caused the guidewire to fracture.The guidewire fragment was not removed from the body.

• 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: 23535535
• Report Number: 2124215-2025-79615
• Device Sequence Number: 15999070
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: (01)08714729228363(17)270525(10)36827245
• 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
• Report Date (Section B): 02/26/2026

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: H749236310030
• Device Catalogue Number: H749236310030
• Device Lot Number: 0036827245
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 11/26/2025; 02/06/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/15/2025; 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2025
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 66 KG