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

Model Number	H749394672000
Medical Device Problem Codes	Entrapment of Device (1212); Nonstandard Device (1420); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the burr was stuck in the lesion.The target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery.A 2.00mm rotapro was selected for use and speed was set at 180,000 rpm.After 2 ablations, the device stalled and the burr became stuck within the lesion.The proximal part of the drive shaft was cut and the device was released by utilizing the guide catheter to press on the area where the burr was stuck.The burr and guidewire were then removed as one unit.The procedure was completed using another of the same device.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by manufacturer.The complaint device was received for product analysis.A visual inspection of the device found that the distal end of the coil was stretched, kinked and detached.The returned wire was able to be removed from the rotapro with no resistance or issue proximally as the distal end of the wire failed to return.The wire was fed into the returned guide catheter to confirm the burr was not lodged within the device.The wire was able to be inserted and failed to encounter any resistance.The burr to the rotapro failed to return for further analysis.After destructive testing was performed, it was found that the drive shaft (turbine) was corroded, indicating the presence of dried saline within the device.During device-to-device interaction test, when the rotapro advancer was connected to the rotapro console and the ablation button was pressed, the device stalled and did not run.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the burr was stuck in the lesion.The target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery.A 2.00mm rotapro was selected for use and speed was set at 180,000 rpm.After 2 ablations, the device stalled and the burr became stuck within the lesion.The proximal part of the drive shaft was cut and the device was released by utilizing the guide catheter to press on the area where the burr was stuck.The burr and guidewire were then removed as one unit.The procedure was completed using another of the same device.There were no patient complications, and patient is stable post procedure.

• Brand Name: ROTAPRO?
• 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: 23607535
• Report Number: 2124215-2025-83684
• Device Sequence Number: 21273572
• Product Code: MCX
• UDI-Device Identifier: 08714729999591
• UDI-Public: (01)08714729999591(17)270617(10)36775897
• 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): 02/16/2026

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: H749394672000
• Device Catalogue Number: H749394672000
• Device Lot Number: 0036775897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2025
• 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