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

Model Number	420-006
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
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.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 lesion in the superficial femoral artery (sfa).A spectranetics turbo-elite laser atherectomy catheter, along with a non-philips guidewire and non-philips introducer sheath, were used to treat the patient.During use, the turbo-elite became stuck in the introducer sheath; therefore, the turbo-elite and introducer sheath were removed together.A new turbo-elite and introducer sheath were used, and the treatment was completed.There was no reported patient harm.This report is being submitted due to removal as a system.There is potential for harm if it were to recur.
Additional Manufacturer Narrative
H3) the turbo-elite was returned intact to a non-philips introducer sheath.Visual inspection of the turbo-elite found slight wrinkles in the working length.During functional testing, the introducer sheath was unable to be removed.Therefore, the introducer sheath was cut open to reveal the inner lumen, and heavy biologics clogging the lumen were observed.The device was soaked and re-evaluated, and after soaking, the introducer sheath was still unable to be removed, with slight biologics still present.H6) based on the device evaluation and investigation, the probable cause of the turbo-elite getting stuck 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 are 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: 23327733
• Report Number: 3007284006-2025-00218
• Device Sequence Number: 10616795
• Product Code: MCW
• UDI-Device Identifier: 00813132024758
• UDI-Public: (01)00813132024758(17)270811(10)0303551044
• 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): 11/21/2025

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: 420-006
• Device Catalogue Number: 420-006
• Device Lot Number: 0303551044
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• 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: 6F INTRODUCER SHEATH (MANUFACTURER UNK); GUIDE WIRE (MANUFACTURER, SIZE UNK); PHILIPS LASER SYSTEM
• Patient Sex: Unknown