MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO?; catheter, coronary, atherectomy

Model Number	H749394671250
Medical Device Problem Codes	Entrapment of Device (1212); Nonstandard Device (1420); Difficult to Remove (1528); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 date of event: 02/01/2026 used as approximate date as actual date is unknown.E1 initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the burr became stuck onto the guidewire and difficulty removal occurred.A 1.25mm was selected for use.During the procedure, it was noted that the burr stalled and could not be removed, as it felt like it was stuck on the guidewire rather than in the stenosis.The procedure was completed with a different device.There were no patient complications, and the patient fully recovered.
Event or Problem Description
It was reported that the burr became stuck onto the guidewire and difficulty removal occurred.A 1.25mm was selected for use.During the procedure, it was noted that the burr stalled and could not be removed, as it felt like it was stuck on the guidewire rather than in the stenosis.The procedure was completed with a different device.There were no patient complications, and the patient fully recovered.
Additional Manufacturer Narrative
B3 date of event: 02/01/2026 used as approximate date as actual date is unknown.E1 initial reporter phone: (b)(6).With all the available information, boston scientific concludes: device history record review: a review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the event.Device technical analysis: the device was not returned to the complaint investigation site for analysis.Labeling review: based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.Risk review: a risk review performed for the rotapro device confirmed that the events of device stall, device difficult/unable to withdraw, and stuck on wire are known events defined in the products risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: as the reported events do not indicate any device damages or failures during unpackaging, preparation, or testing, it was considered likely that the reported events occurred due to factors encountered during the procedure.Therefore, based on a thorough review of the dhr and reported complaint, the most probable cause for this complaint was considered adverse event related to 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 ; +1(763)494-1632
• MDR Report Key: 24664553
• Report Number: 2124215-2026-15566
• Device Sequence Number: 9243503
• Product Code: MCX
• UDI-Device Identifier: 08714729999560
• UDI-Public: (01)08714729999560(17)270728(10)37069575
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2026

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: H749394671250
• Device Catalogue Number: H749394671250
• Device Lot Number: 0037069575
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/11/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 04/08/2026; 07/09/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 05/07/2026; 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2025
• 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