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

Model Number	H749394671750
Medical Device Problem Codes	Mechanical Problem (1384); Nonstandard Device (1420); Output Problem (3005); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a brake issue occurred.The 75% stenosed target lesion was location in the moderately tortuous and severely calcified mid to distal left anterior descending artery.A 1.75mm rotapro was selected for use.During the procedure, upon ablation at a set speed of 180,000 rpm, a strange continuous low cutting sound was noted.The wire fixation was insufficient and felt less secure with slight resistance.During withdrawal, the dynaglide was rotating at higher speed of 150,000 rpm due to a console issue.The procedure continued without use of dynaglide mode and the burr and wire were removed together.The procedure was completed with another of same device.There were no patient complications were reported.
Event or Problem Description
It was reported that a brake issue occurred.The 75% stenosed target lesion was location in the moderately tortuous and severely calcified mid to distal left anterior descending artery.A 1.75mm rotapro was selected for use.During the procedure, upon ablation at a set speed of 180,000 rpm, a strange continuous low cutting sound was noted.The wire fixation was insufficient and felt less secure with slight resistance.During withdrawal, the dynaglide was rotating at higher speed of 150,000 rpm due to a console issue.The procedure continued without use of dynaglide mode and the burr and wire were removed together.The procedure was completed with another of same device.There were no patient complications were reported.
Additional Manufacturer Narrative
H6 device code: updated.With all the available information, boston scientific concludes: device analysis findings: the device was returned.Analysis found that during device testing, a test wire could be inserted successfully without issue which remained within the device for further testing.After connecting the rotapro system to the rotapro console, when the ablation button was pressed, the device stalled and the sound of air could be heard escaping the device during the stall.Despite the stall, additional testing to determine functionality of the brake occurred.It was found that the brake was unable to engage and disengage properly with the wire.After destructive testing, it was found that the driveshaft (turbine) was corroded, indicating the presence of dried saline within the device which is considered likely attributable to the cause of the stall during analysis.During brake analysis, the collet was found to be corroded preventing proper ability to engage and disengage with the test wire.Parylene coating voids were found present at approximately 7mm of the pcba board.Device history record (dhr) review: review confirmed that the device met all material, assembly, and performance specifications prior to distribution.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, the most probable cause for this complaint was considered adverse event related to procedure.Product analysis failed to confirm the reported events as clinical circumstances could not be replicated.

• 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(612)875-7234
• MDR Report Key: 25876858
• Report Number: 2124215-2026-38763
• Device Sequence Number: 20844917
• Product Code: MCX
• UDI-Device Identifier: 08714729999584
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

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: 0038886366
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2026
• 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: 06/24/2026
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2026
• 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