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

Model Number	420-006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Embolism/Embolus (4438)
Date of Event	08/11/2025
Type of Reportable Event	Serious Injury
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.H3) the device was discarded; thus no investigation could be completed.H6) embolism and re-occlusion are known risks of complication with use of the turbo-elite device.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 slightly calcified plaque lesion in the distal superficial femoral artery (sfa) and proximal popliteal artery.A spectranetics turbo-elite laser atherectomy catheter was used to treat the patient.After treatment, imaging showed what appeared to be dislodged plaque that had embolized.A filter and balloon were placed to capture the embolism, and the filter was removed from the patient.At this time, it was noticed that there was further embolization in the tibioperoneal (tp) trunk; therefore, a medtronic spiderfx embolic protection device was used to capture and remove the embolism.Once removed, the tp vessels were filling properly.However, later that week, the patient returned for follow-up, and ultrasound detected that the patient had re-occlusion, which was larger than the original treatment site.The pedal vessels were showing very little blood flow; thus, a stent was placed, and the patient was scheduled for surgery at a later date.This report captures the turbo-elite in use in the area where an embolism and re-occlusion occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.

• 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: 22973734
• Report Number: 3007284006-2025-00165
• Device Sequence Number: 15682950
• Product Code: MCW
• UDI-Device Identifier: 00813132024758
• UDI-Public: (01)00813132024758(17)270603(10)0303491335
• 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
• Report Date (Section B): 09/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 420-006
• Device Catalogue Number: 420-006
• Device Lot Number: 0303491335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2025
• 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: ABBOTT 0.014 SPARTACORE GUIDEWIRE.; COOK MEDICAL 6F ANSEL INDRODUCER SHEATH.; PHILIPS LASER SYSTEM.
• Patient Sex: Unknown