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

Model Number	H749394671750
Medical Device Problem Codes	Nonstandard Device (1420); Output Problem (3005); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1-initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the procedure was cancelled.A 1.75mm rotapro was selected for use.During the procedure, inside the patient, the device could not switch between high and low speed.The procedure was not completed.The patient was stable.
Event or Problem Description
It was reported that the procedure was cancelled.A 1.75mm rotapro was selected for use.During the procedure, inside the patient, the device could not switch between high and low speed.The procedure was not completed.The patient was stable.
Additional Manufacturer Narrative
Investigation results: device evaluated by manufacturer.The complaint device was received for product analysis.A visual inspection of the device did not identify any damages or defects.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.During analysis, when compressing the air/gas line to extend the run cycle, the dynaglide mode change button, and the ablation button were tested and found to respond when pressed on/off with no resistance or issues.No other issues were identified during the product analysis.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.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: based on a thorough review of the reported complaint and analysis of the complaint device, the most probable cause for this complaint and confirmed damage was considered adverse event related to procedure.The dried saline in the device is not considered to be related to the reported event that was encountered during the procedure.H6-device codes: corrected.E1-initial reporter phone: (b)(6).

• 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: 24292513
• Report Number: 2124215-2026-07127
• Device Sequence Number: 10165693
• Product Code: MCX
• UDI-Device Identifier: 08714729999584
• UDI-Public: (01)08714729999584(17)270820(10)37255339
• 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
• Report Date (Section B): 05/05/2026

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: H749394671750
• Device Catalogue Number: H749394671750
• Device Lot Number: 0037255339
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2025
• 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 Age: 65 YR
• Patient Sex: Female
• Patient Weight: 67 KG