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

Model Number	420-159
Medical Device Problem Codes	Material Separation (1562); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A3) patient gender - not available from facility.A5/a6) patient ethnicity and race - not available from facility.B6) relevant test/laboratory data - 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 moderately calcified lesion in the mid superficial femoral artery (sfa).During use of a spectranetics turbo-elite laser atherectomy catheter, exposed fibers were observed.The turbo-elite was removed and angioplasty was performed to complete the procedure.No patient injury reported.This event is being reported for unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
B5) based on the device evaluation, this event has been determined as no longer reportable.D9/h3) the turbo-elite was returned for evaluation.H3) visual inspection found the working length in good condition, with no fibers exposed.Medical device problem code is corrected from a0413: material separation to a24: no malfunction.H6) based on the device evaluation, no problem was detected; therefore, the reported complaint 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.
Event or Problem Description
This product problem is no longer reportable because no breach (exposed fibers) in the outer jacket was observed during the product evaluation; therefore, there was no unintended radiation exposure.

• 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: 23472915
• Report Number: 3007284006-2025-00233
• Device Sequence Number: 18701446
• Product Code: MCW
• UDI-Device Identifier: 00813132024765
• UDI-Public: (01)00813132024765(17)270729(10)0303536479
• 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,Followup
• Report Date (Section B): 12/16/2025

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: 420-159
• Device Catalogue Number: 420-159
• Device Lot Number: 0303536479
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2025
• 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: BOSTON SCIENTIFIC 0.014 GUIDEWIRE.; PHILIPS LASER SYSTEM.; TERUMO 6F INTRODUCER SHEATH.
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 58 KG