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

Model Number	417-152
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a chronic total occlusion (cto) of a moderately calcified fibrous lesion in the mid superficial femoral artery (sfa).A spectranetics turbo-elite laser atherectomy catheter was used to treat the patient.When the procedure was completed and the turbo-elite was removed, the physician noticed the tip of the catheter was charred and discolored.The procedure was completed with no reported patient harm.During device evaluation, the outer jacket was found melted and breached near the distal tip.This event is being reported for unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
A2): patient''s date of birth, age unk.A3): patient''s gender unk.A4): patient''s weight unk a5a./5b.): patient''s ethnicity/ra.Ce unk.B6): relevant tests/laboratory data unk.B7): other relevant history unk.H3): the turbo-elite device was returned for evaluation.Visual inspection found extensive epoxy wear and charred material surrounding the distal tip.The outer jacket was melted and breached, just proximal to the fuse at the distal tip, with no broken fibers identified.No other damage was observed along the working length, bifurcate, or tail tube.It was confirmed that proper flushing technique, in accordance with the ifu, was performed throughout the procedure.H6): based on the device evaluation and completion of the investigation, it has been determined that the patient''s condition/target lesion (cto) caused or contributed to the difficulty of hydration reaching the treatment site.The lack of hydration resulted in the damage noted near the distal tip of the 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.

• 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: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 18489718
• Report Number: 3007284006-2024-00004
• Device Sequence Number: 3666723
• Product Code: MCW
• UDI-Device Identifier: 00813132024734
• UDI-Public: (01)00813132024734(17)250809(10)FAZ23H02A
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2024

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: 08/09/2025
• Device Model Number: 417-152
• Device Catalogue Number: 417-152
• Device Lot Number: FAZ23H02A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2023
• 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 0.018 GUIDE WIRE; CORDIS BRITE TIP 6F INTRODUCER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Sex: Unknown