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

Model Number	H749395141750
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a burr detachment occurred.The 80% stenosed target lesion was located in the moderately tortuous and calcified peripheral artery.A 1.75mm peripheral intervention rotapro burr-advancer was selected for use.During the procedure, when crossing the lesion, it was noted that the burr was fractured at the shaft close to the burr.The physician immediately pulled the wire back and was able to retrieve the burr mounted on the wire.The procedure was completed with another of the same device.No patient complications reported.

• Brand Name: PERIPHERAL ROTAPRO?
• 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; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22324288
• Report Number: 2124215-2025-40579
• Device Sequence Number: 8819170
• Product Code: MCW
• UDI-Device Identifier: 00191506007133
• UDI-Public: (01)00191506007133(17)261002(10)34976871
• Combination Product (Y/N): N
• PMA/510(K) Number: K220962
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2025

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 Expiration Date: 10/02/2026
• Device Model Number: H749395141750
• Device Catalogue Number: H749395141750
• Device Lot Number: 0034976871
• 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: 06/02/2025
• Initial Report FDA Received Date: 06/24/2025
• Date Device Manufactured: 10/02/2024
• 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 Age: 84 YR
• Patient Sex: Male
• Patient Weight: 82 KG