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

Model Number	417-152
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a moderately calcified lesion in the mid superficial femoral artery (sfa).A spectranetics turbo-elite laser atherectomy catheter, along with a non-philips guidewire were being used to treat the patient.Upon removal from the packaging, it was noted that the turbo-elite was twisted and crimped.When attempting to load the device over the guidewire, the turbo-elite became stuck on the guidewire; therefore, removed together.A new turbo-elite and guidewire 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
A3: patient gender: 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.
Additional Manufacturer Narrative
H3) the turbo-elite device was returned for evaluation without the non-philips guidewire.Visual inspection found the device and outer jacket were severely twisted with kinking along the working length.During functional testing, the majority of the fibers within the twisted section appeared to be broken and exposed, with laser light emitting though the outer jacket.Utilizing a 0.014 laboratory guidewire, the guidewire was unable to pass the bifurcate hub.H6) based on the device evaluation and investigation, the cause of the reported failure could not be established; however, if damage is observed to the device upon initial inspection, the device should not be used.The ifu states, "before use, visually inspect the sterile package to ensure that seals have not been broken.All equipment to be used for the procedure, including the catheter, should be examined carefully for defects.Examine the laser catheter for bends, kinks or other damage.Do not use if it is damaged." type of investigation code b01 replaced (from b17).Investigation findings code c0706 replaced (from c20).Investigation conclusions code d15 and d1101 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: 23414981
• Report Number: 3007284006-2025-00226
• Device Sequence Number: 18778056
• Product Code: MCW
• UDI-Device Identifier: 00813132024734
• UDI-Public: (01)00813132024734(17)270925(10)0303580956
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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: 417-152
• Device Catalogue Number: 417-152
• Device Lot Number: 0303580956
• 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: 10/07/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2025
• 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 0.018 COMMAND GUIDEWIRE.; BIOTRONIK 5F INTRODUCER SHEATH.; PHILIPS LASER SYSTEM.
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White