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

Model Number	420-006
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A peripheral atherectomy procedure commenced using a spectranetics turbo elite laser atherectomy catheter and an abbott.018 command wire to treat the patient.During use, it was reported the turbo elite burned the guide wire inside the patient; therefore, removed as a system.A second catheter and guide wire were used to complete the procedure with no reported patient harm.During initial device evaluation, it was discovered that the fuse between the distal marker band and the outer jacket was compromised, resulting in exposed fibers.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/race unk.B6): relevant tests/laboratory data unk.B7): other relevant history unk.H3/h6): although initial findings were reported, the evaluation and investigation is ongoing; a supplemental mdr will be submitted upon completion.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
Additional information: the procedure was performed to treat a moderately calcified, fibrous lesion in the mid superficial femoral artery (sfa).In addition, proper flushing technique was performed during the procedure.
Additional Manufacturer Narrative
A2): patient's date of birth, age populated.A3): patient's gender populated.A4): patient's weight populated.A5a./5b.): patient's ethnicity/race populated.B5): indication for procedure and further case detail populated.B7): other relevant history populated.H3): the turbo-elite catheter was returned along with a non-philips guide wire, protruding from both ends of the catheter.Microscopic inspection found gaps in the outer jacket, exposing the fibers in the fuse area (where outer jacket meets distal marker band).Additionally, an unknown material was noted at the fuse area, extending distally across the marker band.During functional testing, an attempt was made to remove the unknown material; the material pulled on the outer jacket and caused it to pull back, exposing the fibers at the fuse area, with no broken fibers observed.Analysis of the unknown material identified it as closely resembling pebax (outer jacket material); this determined that the outer jacket had melted in the fuse area.At the distal tip, the fibers were fractured and charred, with significant erosion.Visual inspection of the guide wire found a portion of the blue coating missing, and the coating located at the distal tip was burnt and charred.Difficulty was experienced when removing the guide wire from the catheter, resulting in the coating peeling off.Upon removal, heavy biologics were observed on the guide wire and distal tip of the catheter.It is likely that the location of the catheter's distal tip within the target lesion resulted in a lack of hydration in the area of lasing, and caused excessive energy buildup, resulting in the damage noted.H6): based on additional information and further review, the cause for the reported complaint cannot be determined.However, patient morphology likely contributed to the difficulty of hydration reaching the treatment site.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: 17557740
• Report Number: 3007284006-2023-00014
• Device Sequence Number: 19733072
• Product Code: MCW
• UDI-Device Identifier: 00813132024758
• UDI-Public: (01)00813132024758(17)250420(10)FBA23D13A
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2023

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: 04/20/2025
• Device Model Number: 420-006
• Device Catalogue Number: 420-006
• Device Lot Number: FBA23D13A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• 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: 08/16/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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: ABBOTT .018 CONNECT WIRE REFERENCE #1012592; GUIDE CATHETER MANUFACTURER/SIZE UNK; INTRODUCER SHEATH MANUFACTURER/SIZE UNK; SECOND CATHETER MANUFACTURER/SIZE UNK; SECOND GUIDE WIRE MANUFACTURER/SIZE UNK; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White