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	01/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A peripheral atherectomy procedure commenced, and a spectranetics turbo-elite laser atherectomy catheter was used to treat the patient.While attempting to push the turbo-elite into the non-philips 6f introducer sheath, resistance was encountered.The outer jacket appeared to have a tear, and red light could be seen on the side of the jacket.The turbo-elite was removed and a new device 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
H3/h6): the turbo-elite device was not returned; thus, no returned product investigation was performed and a cause for the reported failure could not be confirmed.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
D4): device serial number populated.D9): the turbo-elite device was returned to the manufacturer 19feb2025.H3): visual inspection found a breach in the jacket along the working length.In the area of the breach, a kink/wrinkle, melted jacket, and broken fibers were visible.At the distal tip, there was a slight indention/kink and the outer jacket and fibers appeared to be twisted.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: 21400825
• Report Number: 3007284006-2025-00033
• Device Sequence Number: 21160166
• Product Code: MCW
• UDI-Device Identifier: 00813132024697
• UDI-Public: (01)00813132024697(17)261031(10)0303329503
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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 Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: 0303329503
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2024
• 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: GUIDE WIRE, MANUFACTURER/SIZE UNK.; INTRODUCER SHEATH, MANUFACTURER/SIZE UNK.; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM.
• Patient Sex: Unknown