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

Model Number	H802224360021
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that device failure to adjust speed occurred.A rotablator console was selected for use.During the procedure, it was noted that the device was unable to switch between high and low speed.The procedure was completed with the original device.The patient is stable, sedated with local anesthesia, and with no patient complication or other additional intervention reported.
Additional Manufacturer Narrative
D4: catalog number: corrected.D4: model number: corrected.D2b: pro code (product code): mcx.G4: premarket/510(k) #: p900056.E1: initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that device failure to adjust speed occurred.A rotablator console was selected for use.During the procedure, it was noted that the device was unable to switch between high and low speed.The procedure was completed with the original device.The patient is stable, sedated with local anesthesia, and with no patient complication or other additional intervention 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; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21962397
• Report Number: 2124215-2025-25562
• Device Sequence Number: 7272889
• Product Code: MCW
• UDI-Device Identifier: 08714729353317
• UDI-Public: (01)08714729353317
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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: H802224360021
• Device Catalogue Number: H802224360021
• Device Lot Number: RC400256
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 05/20/2025
• Date Device Manufactured: 11/11/2014
• 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