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

Model Number	410-152
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	03/04/2026
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.D4) device serial number - not available from facility.H3/h6) the turbo-elite device was not returned, thus no 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 patient with use of a spectranetics turbo-elite laser atherectomy catheter.During use, the laser burned through the outer jacket.The catheter was removed and a new turbo-elite was used to complete the procedure.No patient injury reported.This event is being reported for unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
D4: device serial number has been added.H3: the turbo-elite was returned for evaluation.Visual inspection found a kink and a breach 1073 mm from the distal tip with multiple broken fibers.A second kink and breach was present 1066 mm from the distal tip with no broken fibers, and a third kink and breach were observed 1099 mm from the distal tip with no broken fibers visible.Additionally, a puncture was noted approx.881 mm and the outer jacket was bunched together 72 mm from the distal tip with no broken fibers.H6) based on the device evaluation and investigation, this has been determined to be a use related failure.Historically, the manufacturer has seen this failure when the force required to advance and maneuver is greater than the force that the working length can accommodate.When these forces are applied to the side of the outer jacket, the device becomes kinked.Broken fibers in the area redirect the laser energy, which creates a breach in the outer jacket.Type of investigation code b01 replaced (from b17).Investigation findings code c0706 replaced (from c20).Investigation conclusions code d1102 replaced (from d14).All other codes remain applicable as listed in the initial mdr.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: 24680033
• Report Number: 3007284006-2026-00100
• Device Sequence Number: 9653238
• Product Code: MCW
• UDI-Device Identifier: 00813132024697
• UDI-Public: (01)00813132024697(17)271215(10)0303657650
• 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): 04/28/2026

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: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: 0303657650
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2025
• 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: GUIDEWIRE (SIZE, MANUFACTURER UNK); INTRODUCER SHEATH (SIZE, MANUFACTURER UNK); PHILIPS LASER SYTEM
• Patient Sex: Unknown