MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE DRIVE; CATHETER, CORONARY, ATHERECTOMY

Model Number	2077-02
Medical Device Problem Codes	Nonstandard Device (1420); Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	06/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the rotawire became detached and emergency surgery was performed.The target lesion was located in the highly calcified proximal right coronary artery.A rotawire drive and a 1.50mm rotapro were selected for use.During the procedure, upon advancing the device in a dynaglide mode into the lesion, resistance was felt near the non-bsci guide catheter outlet.Consecutively, the wire became detached and perforated the artery.Hemostasis could not be achieved after various measures were taken, requiring additional surgery to be performed, and the wire fragment was removed.It was thought that the guide catheter deformation was due to the transcatheter aortic valve (tavi) jailing the coronary artery that causes the very high resistance, leading to the detachment.No further patient complications were reported.
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).Initial reporter city: (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
Initial reporter address 1: (b)(6).Initial reporter city:(b)(6).
Event or Problem Description
It was reported that the rotawire became detached and emergency surgery was performed.The target lesion was located in the highly calcified proximal right coronary artery.A rotawire drive and a 1.50mm rotapro were selected for use.During the procedure, upon advancing the device in a dynaglide mode into the lesion, resistance was felt near the non-bsci guide catheter outlet.Consecutively, the wire became detached and perforated the artery.Hemostasis could not be achieved after various measures were taken, requiring additional surgery to be performed, and the wire fragment was removed.It was thought that the guide catheter deformation was due to the transcatheter aortic valve (tavi) jailing the coronary artery that causes the very high resistance, leading to the detachment.No further patient complications were reported.It was further reported that the 90-99% stenosed target lesion was located in the moderately tortuous and severely calcified proximal right coronary artery.During the procedure, the speed was set to 180,000rpm.However, a high abnormal sound was heard in the guiding catheter.
Event or Problem Description
It was reported that the rotawire became detached and emergency surgery was performed.The target lesion was located in the highly calcified proximal right coronary artery.A rotawire drive and a 1.50mm rotapro were selected for use.During the procedure, upon advancing the device in a dynaglide mode into the lesion, resistance was felt near the non-bsci guide catheter outlet.Consecutively, the wire became detached and perforated the artery.Hemostasis could not be achieved after various measures were taken, requiring additional surgery to be performed, and the wire fragment was removed.It was thought that the guide catheter deformation was due to the transcatheter aortic valve (tavi) jailing the coronary artery that causes the very high resistance, leading to the detachment.No further patient complications were reported.It was further reported that the 90-99% stenosed target lesion was located in the moderately tortuous and severely calcified proximal right coronary artery.During the procedure, the speed was set to 180,000rpm.However, a high abnormal sound was heard in the guiding catheter.
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Visual and microscope inspection revealed only a portion of the distal end of the guidewire was returned for analysis.The body of the guidewire was kinked.The kink on the body was measured from distal to proximal and the distance where the kink was found is 1-2.0 in.The spring tip was observed bent.Dimensional inspection revealed that 124.0 in of the guidewire were detached and did not return for analysis.

• Brand Name: ROTAWIRE DRIVE
• 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: 22609895
• Report Number: 2124215-2025-47529
• Device Sequence Number: 5457493
• Product Code: MCX
• UDI-Device Identifier: 08714729996248
• UDI-Public: (01)08714729996248(17)260215(10)33441767
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/27/2026

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 Expiration Date: 02/15/2026
• Device Model Number: 2077-02
• Device Catalogue Number: 2077-02
• Device Lot Number: 0033441767
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 08/08/2025; 01/21/2026
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 09/03/2025; 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER - ASAHI INTECC HYPERION 7F JR4.0SH; GUIDE CATHETER - ASAHI INTECC HYPERION 7F JR4.0SH; GUIDE CATHETER - ASAHI INTECC HYPERION 7F JR4.0SH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown