MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTABLATOR?; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	H802224360021
Medical Device Problem Codes	Defective Device (2588); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code: mcx.G4 - premarket / 510(k) #: p900056.
Event or Problem Description
It was reported that the procedure was cancelled.Ace rotablator was selected for use.Prior to procedure, the foot pedal dynaglide mode was not working.The case was postponed, and there was no patient complications 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.Investigation conclusion: based on a thorough review of the reported complaint, the cause of the reported procedure cancelled/rescheduled event was due to the foot pedal not working, but the cause for the foot pedal not working could not be determined.The investigation conclusion code of cause not established was selected.
Event or Problem Description
It was reported that the procedure was cancelled.A ce rotablator was selected for use.Prior to procedure, the foot pedal dynaglide mode was not working.The case was postponed, and there was no patient complications reported.

• Brand Name: ROTABLATOR?
• Common Device Name: CATHETER, PERIPHERAL, 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: 21778057
• Report Number: 2124215-2025-18095
• Device Sequence Number: 12740227
• Product Code: MCW
• UDI-Device Identifier: 08714729353317
• UDI-Public: (01)08714729353317(11)220706(10)FP47416
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121774
• 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): 04/01/2026

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: H802224360021
• Device Catalogue Number: H802224360021
• Device Lot Number: FP47416
• 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: 03/09/2025
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 04/01/2026
• Date Device Manufactured: 07/06/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown