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

Model Number	2077-02
Medical Device Problem Codes	Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the rotapro burr became stuck with the rotawire.The 90% stenosed target lesion was located in the severely calcified left main trunk (lmt).A 1.50mm rotapro and a rotawire were selected for use.During insertion, it was noted that the rotapro burr became stuck with the rotawire.It was not released from being stuck, and the rotapro burr was removed from the body together with the rotawire.The procedure was completed with another of the same device.There were no patient injury and the patient was in good condition after the procedure.
Event or Problem Description
It was reported that the rotapro burr became stuck with the rotawire.The 90% stenosed target lesion was located in the severely calcified left main trunk (lmt).A 1.50mm rotapro and a rotawire were selected for use.During insertion, it was noted that the rotapro burr became stuck with the rotawire.It was not released from being stuck, and the rotapro burr was removed from the body together with the rotawire.The procedure was completed with another of the same device.There were no patient injury and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination revealed that the device returned without the rotaburr loaded on it.Therefore, no sign of jamming could be found.The body of the guidewire was bent/kinked.The kinks/bents on the body were measured from proximal to distal and the distances where the kink were found.A microscopic examination revealed that a portion of the distal end was detached.

• 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: 22843834
• Report Number: 2124215-2025-56517
• Device Sequence Number: 9580896
• Product Code: MCX
• UDI-Device Identifier: 08714729996248
• UDI-Public: (01)08714729996248(17)270221(10)35910275
• 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
• Report Date (Section B): 10/28/2025

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 Model Number: 2077-02
• Device Catalogue Number: 2077-02
• Device Lot Number: 0035910275
• 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: 07/29/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2025
• 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 Sex: Unknown