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

Model Number	414-151
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a moderately calcified plaque lesion in the mid anterior tibial (at) artery.A spectranetics turbo-elite laser atherectomy catheter, along with an asahi gladius mongo 0.014 guidewire, was used to treat the patient.After a couple of passes, when trying to remove the turbo-elite from the guidewire, resistance was noted.The turbo-elite was able to move forward; however, when attempting to retract, the guide wire would pull back as well.Therefore, a new guidewire was placed next to the turbo-elite to maintain access, and the turbo-elite and guidewire were removed as a system.A balloon was placed over the new guidewire, and the treatment was completed.There was no reported patient harm.This report is being submitted due to removal as a system.There is potential for harm if it were to recur.
Additional Manufacturer Narrative
A2-a6) patient information - not available from facility.B6/b7) patient information regarding relevant tests/laboratory data or medical history - not available from facility.D4) device serial number - not available from facility.The turbo-elite device was not returned for evaluation, thus no returned product investigation was performed.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.
Additional Manufacturer Narrative
H3): the turbo-elite was returned intact to a non-philips guidewire.Visual inspection of the turbo-elite found broken fibers, and the outer jacket was damaged (wrinkled, crushed, and kinked).During functional testing, the guidewire could not be removed, and while pulling from the proximal end, the outer jacket collapsed.To determine the cause, the outer jacket/surrounding fibers were removed to expose the guidewire within the inner lumen.The inner lumen material was damaged from pulling, but the guidewire did not appear to be kinked.H6): based on the device evaluation and investigation, the probable cause of the turbo-elite getting stuck was lack of guidewire hydration; causing damage to the outer jacket from pulling.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: 22098507
• Report Number: 3007284006-2025-00105
• Device Sequence Number: 7487203
• Product Code: MCW
• UDI-Device Identifier: 00813132024710
• UDI-Public: (01)00813132024710(17)260312(10)FAY24B26A
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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: 03/12/2026
• Device Model Number: 414-151
• Device Catalogue Number: 414-151
• Device Lot Number: FAY24B26A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ASAHI GLADIUS MONGO 0.014 GUIDE WIRE.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.; TERUMO 6F INTRODUCER SHEATH.
• Patient Sex: Unknown