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

Model Number	2077-02
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter city: (b)(6).Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Investigation conclusion: this investigation has been assigned the conclusion code of adverse event related to procedure following a review of the reported event details, available information, and product record review.It is likely that the issues could be related to factors that can occur with the interaction between the rotapro and rotawire, as well as operational factors such as handling/technique at the moment to manipulate both devices, causing the reported events,.
Event or Problem Description
It was reported that the burr became stuck with the guidewire, and a removal difficulty occurred.A 1.50 mm rotapro burr and rotawire drive were selected for use.During withdrawal, when attempting to remove the device after ablation, the wire and burr became trapped and could not be moved.As a result, both the wire and the burr were replaced.The devices were removed normally, and the procedure was completed with another of the same device.There were no patient complications reported.

• 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: 25002432
• Report Number: 2124215-2026-22622
• Device Sequence Number: 9774133
• Product Code: MCX
• UDI-Device Identifier: 08714729996248
• UDI-Public: (01)08714729996248(17)270507(10)36468170
• 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
• Report Date (Section B): 04/27/2026

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: 2077-02
• Device Catalogue Number: 2077-02
• Device Lot Number: 0036468170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 04/27/2026
• Date Device Manufactured: 05/07/2025
• 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