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

Model Number	423-001
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Unintended Radiation Exposure (4565); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a severely calcified lesion in the mid superficial femoral artery (sfa).A spectranetics turbo-elite laser atherectomy catheter, along with a 0.014 guidewire (manufacturer unknown), was used to treat the patient.During use, the guidewire could no longer be advanced; therefore, by choice, the turbo-elite and guidewire were removed as a system.Upon removal, laser light was noted coming from the side of the catheter.The guide wire was removed from the turbo-elite and a new turbo-elite was used with the existing guide wire.Treatment was complete and there was no reported patient harm.This report is being submitted due to unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
A2) patient age and date of birth - not available from facility.A3b) patient gender - not available from facility.A4) patient weight - not available from facility.A5/a6) patient ethnicity and race - 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 for evaluation; 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.
Additional Manufacturer Narrative
H3) the turbo-elite device was returned for evaluation.Visual inspection found wrinkles in multiple locations along the working length.At the distal tip, broken fibers, burnt and melted jacket, and a slight breach was observed.H6) based on the device evaluation and investigation, the broken fibers resulted in the burning/melting of the outer jacket; however, the cause of the broken fibers could not be established.Type of investigation code b01 replaced (from b17).Investigation findings code c0706 replaced (from c20).Investigation conclusions code d15 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: 22185608
• Report Number: 3007284006-2025-00111
• Device Sequence Number: 8571060
• Product Code: MCW
• UDI-Device Identifier: 00813132024772
• UDI-Public: (01)00813132024772(17)261030(10)0303326942
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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 Model Number: 423-001
• Device Catalogue Number: 423-001
• Device Lot Number: 0303326942
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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: 0.018 GUIDE WIRE (MANUFACTURER UNK); 7F INTRODUCER SHEATH (MANUFACTURER UNK); PHILIPS LASER SYSTEM
• Patient Sex: Male