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

Model Number	417-156
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
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.H3) the turbo elite was returned for evaluation.Visual inspection found the tail tube outer jacket separated 1263 mm from the proximal coupler and multiple broken/charred fibers were observed.In the area of the separation, the tail tube appeared to be melted.H6) based on the device evaluation and investigation, the cause could not be established.The damage was confirmed; however, unable to determine if a kink/breach happened first, or if the heat of a broken fiber weakened the material causing it to separate.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 moderate plaque lesion in the mid superficial femoral artery (sfa).A spectranetics turbo-elite laser atherectomy catheter was used to treat the patient.While lasing through the lesion, red laser light was emitting from the tail tube of the device and appeared to be separating.The turbo-elite was removed and a balloon was used to complete the procedure.No patient injury reported.This event is being reported for unintended radiation exposure, potential for harm.

• 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: 25185523
• Report Number: 3007284006-2026-00233
• Device Sequence Number: 18738138
• Product Code: MCW
• UDI-Device Identifier: 00813132024741
• UDI-Public: (01)00813132024741(17)280331(10)0303719202
• 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): 05/15/2026

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: 417-156
• Device Catalogue Number: 417-156
• Device Lot Number: 0303719202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2026
• 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: 0.014 ASAHI MANGO GUIDEWIRE; BOSTON SCIENTIFIC 6F CATAPULT SHEATH; PHILIPS LASER SYSTEM
• Patient Sex: Unknown