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

Model Number	3256
Medical Device Problem Codes	Unstable (1667); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the speed surpassed the set rotational speed.A rotapro console kit was selected for use.During the procedure, the speed was set to 150,000 rpm, however the maximum observed rotational speed reached up to 164,000 rpm in normal mode and dynaglide mode.Tried to dynaglide the speed but would not lower to 60,000 rpm even with different burr sizes.The catheter was removed from the body and the power was turned on and off on the console.Rota was platformed outside the body and catheter reinserted.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Console failed the final functional test.The pneumatic kit from the gold unit was swapped into the console and subsequently tested, that pairing failed the final functional test.The consoles original pneumatic kit was then paired with the front panel from the gold unit.That pairing failed the final functional test.To ensure the gold unit components were functioning properly, the gold units front panel and pneumatic kit were paired in the console.That pairing passed the final functional test without failing at any step.Console failed the visual inspection because the front panel is scratched.
Event or Problem Description
It was reported that the speed surpassed the set rotational speed.A rotapro console kit was selected for use.During the procedure, the speed was set to 150,000 rpm, however the maximum observed rotational speed reached up to 164,000 rpm in normal mode and dynaglide mode.Tried to dynaglide the speed but would not lower to 60,000 rpm even with different burr sizes.The catheter was removed from the body and the power was turned on and off on the console.Rota was platformed outside the body and catheter reinserted.No patient complications were reported.

• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22366905
• Report Number: 2124215-2025-42010
• Device Sequence Number: 15510586
• Product Code: MCX
• UDI-Device Identifier: 08714729975076
• UDI-Public: (01)08714729975076(11)220104(10)RP005173
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P900056/S166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: 3256
• Device Catalogue Number: 3256
• Device Lot Number: RP005173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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