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

Model Number	423-001
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a severely calcified lesion in the superficial femoral artery (sfa).During use of the spectranetics turbo-elite laser atherectomy catheter, a calibration error code was present.The philips system was restarted, but calibration of the catheter was unsuccessful.Therefore, the turbo-elite was removed and a balloon catheter was used to complete the procedure.No patient injury reported.Upon device evaluation, visual inspection found a breach in the jacket 64 mm from the distal end of the bifurcate cover.In the area of the breach, the outer jacket appears torn; however, no broken fibers or melting/charring to the outer jacket was visible.Functional testing for device calibration was not attempted due to the breach in the jacket, thus the error message could not be confirmed.This event is being reported for unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
A2) patient date of birth and age - not available from facility.A4) patient weight - not available from facility.H6) based on the device evaluation and investigation, the cause of the error could not be determined because calibration could not be attempted to replicate the failure, and the cause of the breach 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: 22953531
• Report Number: 3007284006-2025-00164
• Device Sequence Number: 9868306
• Product Code: MCW
• UDI-Device Identifier: 00813132024772
• UDI-Public: (01)00813132024772(17)270310(10)0303428245
• 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): 09/03/2025

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: 423-001
• Device Catalogue Number: 423-001
• Device Lot Number: 0303428245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2025
• 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: ASAHI INTECC GRAND SLAM GUIDE WIRE (SIZE UNK).; MERIT MEDICAL 7F ROADSTER INTRODUCER SHEATH.; PHILIPS LASER SYSTEM.
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White