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

Model Number	410-152
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A peripheral atherectomy procedure commenced to treat a lesion in the patient's distal posterior tibial (pt) artery.The physician chose to use a spectranetics turbo elite laser atherectomy catheter to treat the patient.During use, a tear was noted in the working length of the catheter.The turbo elite was removed from the patient, and the procedure was completed using balloons and other devices with no reported patient harm.This event is being reported for unintended radiation exposure, potential for harm.
Additional Manufacturer Narrative
Patient's date of birth, age unknown.Patient's gender unknown.Patient's weight unknown.Patient's ethnicity/race unknown.Relevant tests/laboratory data unknown.Other relevant history unknown.The device was not returned, thus no investigation could be completed.Since the device was not returned, the reported failure could not be confirmed.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
D9): the device was returned to the manufacturer on 17jan2023.G3): the device evaluation and investigation were completed (b)(6) 2023.H3): a kink was observed approximately 30 inches from the turbo elite''s distal tip.A breach with broken fibers was confirmed at the location of the kink.Black burn marks were visible on the broken fibers.The outer jacket was melted and wrinkles were present at the location of the breach.H6): historically, the manufacturer has observed this failure when excessive forces are applied to the device''s working length.The device becomes kinked and the broken fibers at the area of the kink produce laser energy, which creates a breach in the outer jacket.This failure has been determined to be a use related failure.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: SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 16096582
• Report Number: 1721279-2023-00004
• Device Sequence Number: 6651689
• Product Code: MCW
• UDI-Device Identifier: 00813132024697
• UDI-Public: (01)00813132024697(17)240623(10)FBD22E02A
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 01/24/2023

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: 06/23/2024
• Device Model Number: 410-152
• Device Catalogue Number: 410-152
• Device Lot Number: FBD22E02A
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2022
• 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: GUIDE CATHETER MANUFACTURER/SIZE UNKNOWN; GUIDE WIRE MANUFACTURER/SIZE UNKNOWN; INTRODUCER SHEATH MANUFACTURER/SIZE UNKNOWN; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Sex: Unknown