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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a slightly fibrous lesion in the superficial femoral artery (sfa).A spectranetics turbo-power laser atherectomy catheter was used to treat the patient.During use, the spectranetics cvx-300 excimer laser system displayed an error code, and the catheter could not be recalibrated.Another catheter was used to complete the procedure with no reported patient harm.Upon device evaluation on 30oct2025: visual inspection found chipped and missing fibers and epoxy at the turbo-power distal tip.This report captures the turbo-power with missing material; potential for harm.
Additional Manufacturer Narrative
A3b) patient gender - not available from facility.B5/h3) during functional testing, the catheter calibrated and run at high energy; therefore, unable to replicate the reported complaint.H6) based on the device evaluation and investigation, when/how the chipped and missing epoxy and fibers occurred could not be established.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• 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 ; 719447-2465
• MDR Report Key: 23538539
• Report Number: 3007284006-2025-00243
• Device Sequence Number: 15927010
• Product Code: MCW
• UDI-Device Identifier: 00813132029944
• UDI-Public: (01)00813132029944(17)270707(10)0303514641
• 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): 11/12/2025

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: 420-050
• Device Catalogue Number: 420-050
• Device Lot Number: 0303514641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 0.018 GUIDEWIRE (MANUFACTURER UNK).; 6F TERUMO INTRODUCER SHEATH.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White