MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number	3600
Medical Device Problem Codes	Fracture (1260); Nonstandard Device (1420)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
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 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).
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.
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, and the burr caused the guidewire to fracture.Moreover, the fractured part of the device was not removed intact from the patient's body.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Spring tip was observed bent, stretched, and a portion of it was detached and did not return for analysis.The total length of the guidewire was measured according to the drawing (b)(6) in order to verify if it was according to the specification established on the drawing and the overall length was between the specification established on the drawing, even though a portion of the spring tip was detached and did not return for analysis.The media attached to the parent record shows the device pouch and a label of from another company but does not show any evidence of the reported issue.

• Brand Name: ROTAWIRE AND WIRECLIP TORQUER
• 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; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23534822
• Report Number: 2124215-2025-79614
• Device Sequence Number: 10187075
• Product Code: MCX
• UDI-Device Identifier: 08714729195573
• UDI-Public: (01)08714729195573(17)270106(10)35562682
• 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): 01/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3600
• Device Catalogue Number: 3600
• Device Lot Number: 0035562682
• 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; 12/24/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/15/2025; 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 66 KG