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

Model Number	414-151
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2): patient date of birth unk.B6): relevant tests/laboratory data unk.H3): the turbo-elite and non philips guide wire were returned to the manufacturer.Visual inspection found the guide wire protruding from the turbo-elite proximal end and distal tip.Significant force was required to move the guide wire within the turbo-elite; resistance appeared to be from biologics, as no additional substances or objects were observed when guide wire was moved.Turbo-elite: two kinks were present, at 65 cm and at 95 cm from the proximal end.Beginning 10 cm distal to the bifurcate handle with a total length of 30 cm, the outer jacket was melted and breached.Additional damage included excessive twisting of the outer jacket and multiple broken fibers.Guide wire: heavy biologics coated the surface of the wire.No damage noted to the ends of the guide wire protruding from the device.H6): based on completion of the device evaluation and investigation, this has been determined to be a use related failure.Historically, the manufacturer has seen that during use of the device, heavy biologic buildup creates resistance within the inner lumen, and leads to the damage observed.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, fibrous lesion in the proximal tibioperoneal (tp) trunk.A spectranetics turbo-elite laser atherectomy catheter was used to treat the patient.While lasing, a split in the outer jacket was detected.Therefore, the turbo-elite was removed and a new device was used to complete the procedure with no reported patient harm.This event is being reported for unintended radiation exposure, potential for harm.

• 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: 20348570
• Report Number: 3007284006-2024-00195
• Device Sequence Number: 12744305
• Product Code: MCW
• UDI-Device Identifier: 00813132024710
• UDI-Public: (01)00813132024710(17)260618(10)FAY24E30A
• 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): 10/01/2024

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: 06/18/2026
• Device Model Number: 414-151
• Device Catalogue Number: 414-151
• Device Lot Number: FAY24E30A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2024
• 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 SPARTACORE GUIDE WIRE; COOK MEDICAL 6F INTRODUCER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White