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

Model Number	414-151
Medical Device Problem Codes	Material Separation (1562); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unintended Radiation Exposure (4565); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3/h6): the turbo-elite device was not returned; 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.
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a plaque lesion in the mid posterior tibial (pt) artery.A spectranetics turbo-elite laser atherectomy catheter was used to treat the patient.During calibration of the device, light could be seen from the outer jacket; therefore, the turbo-elite was removed.A new device was used to complete the procedure with no reported harm to the patient or user.This event is being reported for unintended radiation exposure, potential for harm.
Event or Problem Description
This event is no longer reportable for product problem: unintended radiation exposure; potential for harm.Per the returned device analysis, no breach to the outer jacket or red light was observed.
Additional Manufacturer Narrative
B5): this event is no longer reportable after device evaluation and investigation completed.G3): the device evaluation and investigation were completed 10jan2025.H3): the turbo-elite was returned for evaluation.Visual inspection found no breaches or red light observed along the length of the device.H6): based on the device evaluation and investigation, the cause of the red light emitting from the side of the catheter could not be established.Medical device problem code corrected to a24 (from a0413).Hecc code corrected to e2403 (from e2119).Investigation findings code replaced with c19 (from c20).Investigation conclusions code replaced with d15 (from d14).All other codes from the initial mdr remain applicable.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: 21072413
• Report Number: 3007284006-2025-00006
• Device Sequence Number: 8372514
• Product Code: MCW
• UDI-Device Identifier: 00813132024710
• UDI-Public: (01)00813132024710(17)260227(10)FAY24B16A
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170059
• 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): 01/16/2025

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: 02/27/2026
• Device Model Number: 414-151
• Device Catalogue Number: 414-151
• Device Lot Number: FAY24B16A
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• 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: COOK MEDICAL 0.018 ROADRUNNER GUIDE WIRE.; COOK MEDICAL 6F INTRODUCER SHEATH.; LASER SYSTEM, MANUFACTURER/MODEL UNK.
• Patient Sex: Unknown