MAUDE Adverse Event Report: SPECTRANETICS CORPORATION TURBO-ELITE LASER ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	420-159
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a lesion using a spectranetics turbo-elite laser atherectomy catheter.During calibration, the catheter was not recognized by the philips laser system.Troubleshooting was performed, including unplugging and re-plugging the catheter into the laser system; however, the same issue occurred.The procedure was completed without the use of the turbo-elite, with no reported patient harm.During evaluation on (b)(6) 2026, visual inspection found a breach with broken fibers just proximal to the marker band at the distal tip.Calibration was not possible due to the breach and broken fibers.This event is being reported for unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
B6/b7) patient information regarding relevant tests/laboratory data or medical history - not available from facility.H6) based on the device evaluation and investigation, the cause of the reported failure and damage 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-ELITE 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: 24706442
• Report Number: 3007284006-2026-00106
• Device Sequence Number: 10556898
• Product Code: MCW
• UDI-Device Identifier: 00813132024765
• UDI-Public: (01)00813132024765(17)271029(10)0303617877
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K250385
• 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): 03/26/2026

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: 420-159
• Device Catalogue Number: 420-159
• Device Lot Number: 0303617877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2025
• 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: PHILIPS LASER SYSTEM.
• Patient Sex: Unknown