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

Model Number	414-151
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3): the turbo-elite was returned with two guidewires (abbott command (intact to catheter) and abbott spartacore) for evaluation.-visual inspection of the turbo-elite found dried biologics throughout the length of the inner lumen with minor kinks observed.However, the minor kinks would not prevent a guidewire from passing through the lumen.During functional testing, the command guidewire was pulled distally, but considerable resistance was experienced, but when it was removed proximally, no issues were noted.-visual inspection of the command guidewire found a kink, and the green coating material was missing (aligns with the curve on the turbo elite working length).-visual inspection of the spartacore guidewire found multiple kinks that would have been proximally outside of the luer when the turbo elite was at the site of the target lesion.H6): based on the device evaluation and investigation, the cause of the turbo elite becoming stuck on the command guidewire cannot be established.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, plaque lesion in the mid posterior tibial (pt) artery and a peroneal artery.A spectranetics turbo-elite laser atherectomy catheter, along with a abbott 0.014 spartacore guide wire, was used to treat the patient.After a couple of passes with the turbo-elite over the guide wire, the catheter became stuck on the wire.Multiple attempts were made to remove the turbo-elite from the wire; however, attempts were unsuccessful.Therefore, with considerable effort, the guide wire was removed instead.In order to maintain access to the lesion, the turbo-elite was left in place within the patient, and a new abbott 0.014 command guide wire was inserted.About 2/3 of the way through the turbo-elite, advancement of the guide wire took considerable effort, but ultimately reached the turbo-elite distal tip.Lasing was completed on the pt artery, and when trying to remove the catheter from the patient, the same issue occurred, and the wire was stuck inside the device.Both the turbo-elite and the guide wire were removed from the patient, and a new turbo-elite and boston scientific 0.014 thruway guide wire was used to complete the procedure on the peroneal artery with 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.

• 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: 20931379
• Report Number: 3007284006-2024-00234
• Device Sequence Number: 8390728
• Product Code: MCW
• UDI-Device Identifier: 00813132024710
• UDI-Public: (01)00813132024710(17)260207(10)FAY24A22A
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170059
• 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): 12/13/2024

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 Expiration Date: 02/07/2026
• Device Model Number: 414-151
• Device Catalogue Number: 414-151
• Device Lot Number: FAY24A22A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2024
• 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: ABBOTT 0.014 COMMAND GUIDE WIRE; ABBOTT SPARTACORE 0.014 GUIDE WIRE; COOK MEDICAL 5F INTRODUCER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White