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

Model Number	3256
Medical Device Problem Codes	Unstable (1667); Mechanics Altered (2984); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that unstable speed occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified circumflex artery.A 1.50mm, 1.25mm rotapro and console were selected for use.During preparation, the 1.50mm burr stalled briefly.When it went into the patient with a set speed of 165k.The speed reached at a maximum of 200k, and it stalled multiple times and would no longer run as it stuck in the proximal lesion.The device was removed from the body and was changed to a 1.25 burr.When placed prior to the lesion at a set speed of 165k.The rotation speed per minute (rpm) appeared on the screen with a maximum 0f 220k, but no sound of the burr was heard, and no stalled signal was on.The burr was also got stuck in the lesion.The device was removed and completed the procedure with a different device.The procedure got prolonged, but no patient complications were reported.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.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.Risk review: a risk review was completed and confirmed that the event of console- erratic speed (normal mode rotation - speed unstable) and system stall (system - speed too slow) were defined in the risk documentation.These event type have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, no definitive product-related cause could be identified.All available documentation and evidence were evaluated; however, the investigation did not confirm any specific failure mode, contributing factor, or condition that could explain the reported allegation.Therefore, the conclusion code assigned to this investigation is "cause not established".
Event or Problem Description
It was reported that unstable speed occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified circumflex artery.A 1.50mm, 1.25mm rotapro and console were selected for use.During preparation, the 1.50mm burr stalled briefly.When it went into the patient with a set speed of 165k.The speed reached at a maximum of 200k, and it stalled multiple times and would no longer run as it stuck in the proximal lesion.The device was removed from the body and was changed to a 1.25 burr.When placed prior to the lesion at a set speed of 165k.The rotation speed per minute (rpm) appeared on the screen with a maximum 0f 220k, but no sound of the burr was heard, and no stalled signal was on.The burr was also got stuck in the lesion.The device was removed and completed the procedure with a different device.The procedure got prolonged, but 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; 150 baytech dr; san jose CA
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 20206075
• Report Number: 2124215-2024-55894
• Device Sequence Number: 7650084
• Product Code: MCX
• UDI-Device Identifier: 08714729975076
• UDI-Public: 08714729975076
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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: 3256
• Device Catalogue Number: 3256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 04/20/2026
• 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