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	09/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G1): correction was made to manufacturer email address.
Event or Problem Description
A peripheral atherectomy procedure commenced, and a spectranetics turbo-elite laser atherectomy catheter was used to treat the patient.There was melting noted on the working length of the device; therefore, the turbo-elite was removed.A new device was used to complete the procedure with no reported patient harm.Upon completion of the turbo-elite device evaluation on (b)(6)2024, a wrinkle and a breach of the outer jacket was detected.At the area of the breach, the outer jacket was melted, with broken fibers present.This event is being reported for unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
A2-a6): the patient's date of birth, age at time of event, sex, gender, weight, ethnicity, and race are unk.B6/b7): patient information regarding relevant tests/laboratory data or medical history are unk.H3): the turbo-elite device was returned to the manufacturer for evaluation.Visual inspection found a wrinkle and a breach of the outer jacket.At the area of the breach, the outer jacket was melted, with broken fibers present.H6): based on the device evaluation and investigation, this has been determined to be a use related failure.Historically, the device damage has been observed when excessive forces are applied to the side of the outer jacket.The device becomes kinked, and then broken fibers at the area of the kink produce heat, which creates a breach in the outer jacket.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: 21072183
• Report Number: 3007284006-2025-00001
• Device Sequence Number: 19685567
• Product Code: MCW
• UDI-Device Identifier: 00813132024697
• UDI-Public: (01)00813132024697(17)260624(10)FBD24F11A
• 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): 01/03/2025

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: 06/24/2026
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD24F11A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2024
• 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: 01/03/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2024
• 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.; PHILIPS LASER SYSTEM.
• Patient Sex: Unknown