MAUDE Adverse Event Report: Spectranetics Corporation Turbo-Power Laser Atherectomy Catheter; Catheter, Peripheral, Atherectomy

Model Number	420-050
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction

• Brand Name: Turbo-Power Laser Atherectomy Catheter
• Common Device Name: Catheter, Peripheral, Atherectomy
• Manufacturer (Section D): Spectranetics Corporation; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): Spectranetics Corporation; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: nicole worford ; 9965 federal drive; colorado springs, CO 80921 ; +1(719)447-2465
• MDR Report Key: 50226825
• Report Number: 3007284006-2026-00419
• Device Sequence Number: 18733249
• Product Code: MCW
• UDI-Device Identifier: 00813132029944
• UDI-Public: (01)00813132029944(17)271009(10)0303601745
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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 Expiration Date: 10/09/2025
• Device Model Number: 420-050
• Device Catalogue Number: 420-050
• Device Lot Number: 0303601745
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Male